Careers

Schedule: Monday to Friday, 2 PM to 10:30 PM
Pay: $60K-$70K/year
Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company’s mission and vision.  Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects.

Duties/Responsibilities:

• Lead the document control program to ensure procedures meet CGMP requirements
• Manage training documentation and track employee compliance with training plans
• Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc.
• Support in-process and finished product lot acceptance sampling and inspection
• Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier
• Develop and implement corrective and preventive actions geared toward continuous process improvements
• Support the finished product label printing and issuance process
• Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements
• Provide supplier related support to production and receiving inspection team
• Other duties and tasks, as assigned

Required Skills/Abilities:

• Excellent independent judgement and interpersonal skills
• Excellent mathematical, written communication, and verbal communication skills
• Strong technical writing skills and attention to detail
• Knowledge of and proficiency in the use of basic statistics
• Familiarity with Good Manufacturing Practices and FDA Regulations
• Supplier Auditing experience
• Knowledge of ERP System
• Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus

Education and Experience:

• 2-5 years of Quality Assurance experience
• Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing
• B.S. or B.A. on Sciences or a relevant field or equivalent experience
• Professional certification in Quality Engineering or Quality Auditing, preferred

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Pay: $65,000-$75,000
Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company’s mission and vision. Responsible for providing oversight of Quality System elements, including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects.
Maintain the document control program in MasterControl to ensure procedures meet CGMP requirements as a Document Administrator
Organize, file, and maintain record storage, including off-site storage
Issue CGMP documents including Master Batch Production Records, Room and Equipment Logs, etc.
Participate in internal audits to ensure compliance with CGMP regulations and internal procedures
Support external inspections by regulatory bodies and customers by procuring documents and records for review
Manage training documentation and records
Develop and implement corrective and preventive actions geared toward continuous process improvements
Write and implement standard operating procedures to meet and maintain FDA CGMP, USP, and state licensure requirements
Other duties and tasks, as assigned

REQUIREMENTS:
2-5 years of Quality Assurance experience
Pharmaceutical, Medical Device, or biotechnology industry experience
B.S. or B.A. in Sciences or a relevant field or equivalent experience
High proficiency in using Microsoft Word, Excel, Power Point, Outlook
Professional certification in Quality Engineering or Quality Auditing, preferred

Excellent independent judgement and interpersonal skills
Excellent written and verbal communication skills
Strong technical writing skills and attention to detail
Familiarity with Good Manufacturing Practices and FDA Regulations

STAQ Pharma is currently hiring for a formulation technician for their 1st shift

Schedule:

1st shift

Monday to Friday, 6 AM to 2:30 PM
Pay: $22/hour

This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned.

All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required.

Hours of Work: 8-hour shift Monday through Friday. 0600-1430 or 1400-2230.

SAFETY

• Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.
• Authorized to immediately stop any task that is determined to be an imminent hazard.
• Always promote and demonstrate safe work practices and adhere to PPE requirements.
• Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.
• Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift.

PRIMARY RESPONSIBILITIES:

• Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements.
• Learn to utilize all relevant equipment/technology for formulation operations.
• Complete and document required training to gain proficiency for all assigned job tasks.
• Accurately and contemporaneously document all actions performed per GDP standards.
• Assist with classified and non-classified area cleaning and maintenance as required.
• Perform visual inspection, labeling, and additional support tasks as required.
• Make recommendations for process improvements.
• Possess the ability to master multiple processes across different areas.
• Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.
• Maintain a quality focused, “Right First Time”, attitude.
• Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.
• Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.
• Ensure patient safety by understanding you and your team’s impact on product quality.
• Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment.
• Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
• Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.
• High School Diploma or equivalent.
• Must pass a drug test.
• Must speak, write, and read English.
• Must be a team player.
• Must have excellent attention to detail.
• Prior Sterile Compounding and Pharmaceutical Industry experience.
• Prior experience operating manufacturing equipment/machinery.
• Knowledge of FDA guidelines, cGMP, and GDP.
• Willingness to participate in training and gain other certifications as needed.
• Knowledge of basic arithmetic and chemistry calculations.
• Ability to work in a fast-paced environment with dynamic priorities and demands.
• Excellent written and verbal communication skills.
• Desire to expand knowledge and grow with the company.
• Leadership ability.

rt!

STAQ Pharma is currently hiring for a production supervisor to join our team here in the Columbus area

STAQ Pharma, Inc., a leader in the 503B pharmaceutical manufacturing industry, is seeking an experienced and dynamic Manager of Supply Chain to oversee and manage supply chain operations across two key sites: Columbus, OH, and Denver, CO. This role will be physically located at our Columbus, OH facility. The ideal candidate will possess a deep understanding of supply chain management, particularly within the pharmaceutical manufacturing sector, and will be adept at driving efficiency, cost savings, and operational excellence across multi-site operations.

Key Responsibilities:

1. ERP System Implementation:
   • Integrate/convert our current inventory management system into our new ERP system (Microsoft Dynamics 365).
   • Implement barcode scanning/RFID technology for all raw material inventory to enhance accuracy and efficiency.
2. Inventory Management:
   • Utilize the large warehouse capabilities in Columbus to purchase and manage inventory volumes that serve both the Columbus and Denver sites effectively.
   • Coordinate regular truck shipments from Columbus to Denver to support production operations while adhering to Denver’s warehouse constraints.
   • Monitor and manage long lead-time inventory to ensure timely availability of materials for both sites.
   • While the Supply Chain team is built out, the Manager of Supply Chain is expected to be heavily involved in the day-to-day operations. Such as, ordering, safety stock calculations, sourcing, etc.
3. Supply Chain Processes and SOPs:
   • Own, develop, and continuously improve all supply chain-related Standard Operating Procedures (SOPs) and processes to ensure compliance and operational efficiency.
   • Implement best practices and innovative solutions to enhance supply chain operations.
4. Vendor Relations and Contract Negotiations:
   • Establish and maintain strong relationships with vendors to ensure reliable supply and favorable terms.
   • Negotiate contracts, rebate programs, and purchase agreements that yield cost savings and mitigate risks.
   • Identify and manage single points of failure in the supply chain to ensure business continuity.
5. Team Building and Leadership:
   • Responsible for building out the supply chain team over the next year to support the growing needs of the company.
   • Provide leadership, mentorship, and direction to the developing supply chain team to ensure high performance and professional growth.
6. Cost Management and Savings:
   • Develop and execute strategies to optimize procurement and inventory management costs.
   • Analyze and implement opportunities for cost savings without compromising quality or compliance.

Qualifications:

• Bachelor’s degree in Supply Chain Management, Business Administration, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in supply chain management, with at least 2 years in a leadership role preferably within the pharmaceutical or healthcare manufacturing industry.
• Proven experience in ERP system implementation and inventory management.
• Strong knowledge of pharmaceutical manufacturing regulations and requirements.
• Excellent negotiation, communication, and relationship management skills.
• Ability to manage multi-site operations and balance competing priorities effectively.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office Suite and supply chain management software.
• Ability to travel up to 25%
• Proactively formulates activities, sets direction, and prioritizes tasks with minimal management oversight. Strong people management skills.
• Ensure compliance with all relevant laws, regulations, and standards regarding supply chain operations.
• Collaborate with internal departments, such as Production/Operations, Sales, and Finance, to understand their supply chain needs and ensure timely delivery of materials and products.
• Demonstrated willingness to help others and take on duties to make STAQ successful.

Why STAQ Pharma, Inc.:

• Opportunity to lead and innovate within a growing company in the pharmaceutical manufacturing sector.
• Collaborative and dynamic work environment.
• Competitive salary and comprehensive benefits package.
• Opportunity to make a significant impact on the company’s operations and success.

STAQ is currently hiring for a microbiologist to join our team here in Denver.

Schedule:
Monday to Friday, 9 AM to 6 PM
Pay: $70,000-$75,000

At minimum, the role is responsible for reviewing environmental monitoring data, providing support for batch disposition, assist in maintaining facility control, generating appropriate reports, leading quality control deviations/investigations, organizing/implementing appropriate processes and conducting all environmental monitoring validations.
• Organize, monitor, and assist with all production/routine environmental monitoring performance.
• Provide quality control and microbiology support to operations .
• Provide guidance and changes in scheduled cleaning of facility based on shutdown activities and environmental monitoring trending.
• Organize, manage, review and trend all environmental monitoring data .
• Provide trending reports to upper management.
• Lead and draft investigations as they relate to environmental monitoring or quality control deviations.
• Implementing CAPA’s as they relate to routine and production environmental monitoring deviations.
• Solve process, procedural, equipment issues via experimentation or revision of procedures.
• Other duties as assigned .
Experience Required:
B.S. or B.A. in Microbiology or a closely related field / or equivalent experience
• Minimum three (3) years’ experience in a quality control environment
• Experience in a cGMP Environment
• Preferred previous pharmaceutical experience .
• Minimum three (3) years’ experience in a quality control environment
• Experience in a cGMP Environment
• Preferred previous pharmaceutical experience .
Experience with cGMP aseptic manufacturing environments

This entry-level Operations position functions as part of the Production Team and independently performs material handling, cleaning, visual inspection, labeling, and packaging. As personnel develop skills and demonstrate mastery of assigned tasks, Production Technicians may progress to perform additional activities including formulation and classified area cleaning. This position is trained in controlled and classified area gowning and performs majority of job function in Controlled Non-Classified (CNC) and Classified (ISO 8, ISO 7) environments.

Performs all job functions in adherence with cGMP, company policies, and any other quality or regulatory (e.g., OSHA, DEA, FDA, etc.) requirements.

Duties/Responsibilities:

SAFETY

• Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies.
• Immediately stops any task that is determined to be an imminent hazard.
• Promotes and demonstrates safe work practices and adhere to PPE requirements.
• Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds.
• Demonstrates physical ability to lift a minimum of 50 lbs. and push/pull pallets, product containers, etc., multiple times per shift.

PRIMARY RESPONSIBILITIES:

• Performs cleaning activities in the production areas.
• Performs documentation, set-up, cleaning, and maintenance of rooms and equipment. 
• Executes all processes as defined in the batch record, procedures, and work instructions consistent with regulatory/cGMP requirements.
• Performs material handling and material transfer withing warehouse, CNC, and classified areas.
• Performs Visual Inspection of finished products.
• Performs Labeling and Packaging of finished products.
• Performs Formulation of intermediate bulk drug according to batch record.
• Maintains training and qualification in all areas as required.
• Demonstrates basic troubleshooting skills.
• Uses equipment according to procedures and work instructions.
• Completes cGMP documentation reviews as required or assigned.
• Performs other duties as assigned.
• Demonstrates ability to recognize and respond to potential deviations from the defined process.

Required Skills/Abilities:

• Demonstrates ability and motivation to progress to a Production Technician II and/or master multiple processes within assigned work area.
• Demonstrates accountability by arriving at work at scheduled start time, prepared to work in the CNC or classified environment for most of each shift. Recognizes individual and team deviations and accepts responsibility for making corrections and improvements.
• Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism.
• Speaks up and holds others accountable by providing constructive feedback.
• Ensures patient safety by understanding individual and team impact on product quality.
• Participates effectively on a diverse and high performing team. Remains open to new ideas and perspectives, communicate across shifts as required, and complies with procedures to create a safe work environment.
• Demonstrates motivation by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
• Demonstrates courage and innovation by speaking up about viable options for improvements and supporting a path for implementation. 

Education and Experience:

• High School Diploma or equivalent.
• Must pass drug screening and vision screening.
• Must speak, write, and read English.
• Must be a team player.
• 1+ years of continuous work experience
• Prior experience in a regulated manufacturing industry.
• Knowledge of basic arithmetic and chemistry calculations.
• Ability to work in a fast-paced environment with dynamic priorities and demands

STAQ Pharma is currently working hiring for production associates for our 1st and 2nd shift. Come join a team that offers exposure to work in the pharmaceutical manufacturing industry, and grow a career path with our team!
1st shift: Monday to Friday, 6 AM to 2:30 PM – $20/hour
2nd shift: Monday to Friday, 2 PM to 11 PM (or until done) – $22/hour

BENEFITS:
We provide medical, dental & vision insurance, as well as a 401K, Life insurance, voluntary life insurance, long term and short term disability, HSA & FSA, Aflac, LegalShield & IDShield, pet insurance, MetLife & SupportLinc Employee Assistance (mental health support)

This position functions primarily in a controlled-non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will perform labelling, visual inspection, and other duties, such as cleaning, restocking, and waste destruction, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required.

• PRIMARY RESPONSIBILITIES:

Perform manual labeling and visual inspection operations in the CNC environment consistent with established protocols, procedures, and regulatory/cGMP requirements.

• Responsible for acquiring and maintaining visual operator qualification status for syringes.
• Complete and document required training to gain proficiency for all assigned job tasks.
• Accurately and contemporaneously document all actions performed per GDP standards.
• Assist with non-classified area cleaning and maintenance as required.
• Perform waste destruction, material transfer, and additional support tasks as required.
• Make recommendations for process improvements.
• Possess the ability to master multiple processes across different areas.
• Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.
• Must be able to read and write in English

STAQ Pharma is currently hiring for a Quality Assurance Manager in our Denver Facility

Salary: $100K-$110K/year

The Quality Assurance Manager provides leadership in the implementation and oversight of the Quality Management System (QMS) at STAQ Pharma, Inc.

This role gives guidance for resolution of daily quality issues and opportunities for improvement to ensure Current Good Manufacturing Practices (CGMP) compliance.

Large scale enhancement projects to improve process inefficiencies, eliminate risk, and drive towards may be led by the Quality Assurance Manager.

The position leads regulatory inspections and customer audits, and facilitates the supplier management program to ensure the quality of services and incoming goods. Roles and Responsibilities

• Author, review and/or approve Standard Operating Procedures (SOPs) and Work Instructions to maintain compliance with CGMP requirements and product quality standards.
• Oversee the batch review and disposition process to ensure products meet CMGP requirements and all unexplained discrepancies are investigated.
• Manage Quality department metrics for Management Review and routine Key Performance Indicators (KPIs).
• Serve as QA subject matter expert during regulatory inspections and customer audits. Maintain company audit readiness and support document requests made during inspections and audits.
• Perform and/or review deviation and CAPA investigations for root cause analysis, corrective actions, and effectiveness checks. Drive CAPA plans to completion in a timely manner.
• Plan, maintain, and implement the internal audit schedule and ensure audits, responses, and corrective action is taken in a timely manner.
• Lead the supplier management program to evaluate new suppliers, perform ongoing oversight of suppliers including audits, communicate complaints, and manage supplier corrective action requests.
• Review change controls to manage the risk and impact to validated CGMP systems, processes, and equipment.
• Support Quality and company goals related to the QMS.
• Coach and mentor Quality Assurance department staff to support and execute CGMP processes.
• Other duties as assigned.

Qualifications and Education Requirements

• 5 to 7 years experience in a CGMP environment, preferrably in a decision making or leadership role.
• B.S. or B.A., at a minimum.
• Comprehensive knowledge of applicable FDA regulations and guidance documents.
• Previous experience as a key member of regulatory inspections and customer audits.
• Strong analytical knowledge of data and associated statistical tools.
• Technical writing skills to accurately convey information to the intended audience.
• Excellent verbal communication skills.

Preferred Skills

• Experience implementing lean manufacturing and 5S methodologies.
• Advanced Microsoft Office product skills (e.g., Word, Excel).