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

Schedule: Monday to Friday, 6 AM to 2:30 PM
Pay: $23/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.

STAQ Pharma is currently hiring for a Quality Assurance Specialist to join their team for the 1st shift here in Columbus, OH.

The responsibilities of this individual will include

• 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

Qualifications and Education Requirements

• Must be able to read and write in English
• 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

Preferred Skills

• 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
• Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus

Additional Notes

This position will work closely with the Production team and report quality data to the department head, as needed

STAQ Pharma is currently hiring for a quality control specialist to join their team for the 1st shift
Monday to Friday, 6 AM to 2:30 PM

Pay: $60-$65K/year

Quality Control Specialist is responsible for:
Ensuring compliance with cGMP requirements and company procedures.
Providing QC support throughout all departments.

Roles and Responsibilities

Responsibilities for Quality Control Specialist include:
Works effectively and efficiently in a team environment.
Perform review and release of raw materials, API, and excipients.
Coordinates third party sample submission.
Demonstrates the ability to perform detail-oriented work with a high degree of accuracy.
Conduct investigations pertaining to OOS/OOT of raw materials, in-process, and finished product results with production personnel and/or supplier.
Assists with all aspects of the quality system, such as change control, investigations, CAPA, and validation systems to ensure compliance and timely completion of assigned activities.
Stability testing coordination and final report generation.
Review and release of finished product testing results.
Generation of Certificate of Analysis and Finished Good Forms for batch release.
Participate in product development meetings and represent Quality Control.
Assist with the development, management and improvement of quality system processes and procedures to ensure compliance with applicable laws, regulations, and company standards in support of cGMP for pharmaceutical compounding.
Lead/support audits (internal and external) to ensure compliance to CGMP regulations and internal procedures
Performs other duties as assigned.

Qualifications and Education Requirements
BS/BA in microbiology, chemistry, or a relevant field/or equivalent experience.
2-5 years of Quality Control experience.
Experience in a cGMP environment. Preferred Skills
Previous pharmaceutical experience.
Familiarity with 21 CFR Part 11/210/211.
Experience with aseptic manufacturing environments.
Comfortable in a fast-paced, small company

STAQ is currently hiring for a Quality Director to join our team here in the Columbus area.

About Us: STAQ Pharma is a fast-growing pharmaceutical company specializing in 503B outsourcing manufacturing, established in 2017 in Denver, CO. We are committed to delivering high-quality, safe, and compliant products to our clients. As we expand, we are seeking an experienced Quality Director to join our team in Columbus, OH and play a pivotal role in ensuring our quality standards meet and exceed industry regulations.

Job Summary: The Director of Quality will oversee all aspects of quality management, including batch records, batch review, batch release, and deviation investigation. The ideal candidate will have a strong background in cGMP and preferably experience in a 503B outsourcing pharmaceutical manufacturing facility.

Key Responsibilities: In this role, you will develop and implement a comprehensive Quality Management System (QMS) that aligns with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. You will provide strategic direction and leadership to the quality team, ensuring adherence to established quality objectives, policies, and procedures. Your responsibilities will also include overseeing the management of batch records, ensuring accurate documentation, review, and release processes are followed, as well as leading and supporting investigations into deviations, out-of-specification results, and customer complaints, with a focus on implementing effective corrective and preventive actions.

Maintaining up-to-date knowledge of relevant regulations and industry guidelines is critical to this role, as you will be responsible for ensuring compliance with FDA, State Boards of Pharmacy, and other regulatory agencies. Additionally, you will serve as the primary point of contact for regulatory agencies, leading inspections and audits, and ensuring timely and accurate responses to regulatory inquiries. Collaboration with cross-functional teams, including manufacturing, R&D, regulatory affairs, and supply chain, will be essential to ensure quality processes are integrated throughout the product lifecycle. You will also monitor key quality performance indicators (KPIs) and drive continuous improvement initiatives to enhance product quality and compliance.

Qualifications:

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. An advanced degree (e.g., Pharm.D., Ph.D.) is preferred.
• 2-5 years of experience as a Quality Director, with a strong background in cGMP and quality assurance within the pharmaceutical industry.
• Proven experience in batch records, batch review, batch release, and deviation investigations.
• Preferably, experience in a 503B outsourcing pharmaceutical manufacturing facility.
• Strong knowledge of FDA regulations, ICH guidelines, and other relevant quality standards.
• Demonstrated success in managing regulatory inspections and audits.
• Excellent leadership, communication, and problem-solving skills.
• Ability to adapt to a fast-paced, evolving environment and manage multiple priorities.

Why Join Us? At STAQ, you'll have the opportunity to make a significant impact in a growing company. We offer a collaborative and supportive work environment, competitive compensation, and the chance to advance your career.

STAQ Pharma is currently hiring for a filling technician for their 1st and 2nd shifts
Schedule:

2nd shift:

Monday to Friday, 2 PM until done
Pay: $28/hour

This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling 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.

PRIMARY RESPONSIBILITIES:

• Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements.
• Learn to utilize all relevant equipment/technology for filling operations.
• Responsible for acquiring and maintaining classified area gowning qualification.
• 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.

Required Skills:

• Must be able to read and write in English
• 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.

STAQ Pharma is currently hiring a senior quality investigator for our Denver facility

$90-110K/year

The role is responsible for leading the deviation, investigation, and CAPA processes, investigating and closing deviations, identifying trends and recurrent deviations, working, and communicating cross-functionally with other departments to ensure investigations are thorough and efficient, and support Quality department in various tasks. The role also requires taking command in ensuring there is knowledge across the company on the metrics mentioned, and the necessary steps to create a Right First Time (RFT) Culture.

•  Indpendently lead, investigate, and oversee the deviation, investigation process to closure.

•  Identify the underlying causes of deviations by utilizing root cause analysis tools such as Control Charts, Fishbone Diagrams, 6Ms, and 5 Whys, etc.

•  Develop and implement robust Corrective and Preventive Actions (CAPAs) to prevent recurrence of deviations.

•  Monitor deviation metrics to assess trends and drive continuous improvement initiatives.

•  Actively manage deviations to achieve RFT and on-time phase completion.

•  Facilitate weekly/daily management reviews of deviation data.

•  Create and educate on proactive preventative measures for deviations.

•  Collaborate with cross-functional teams to address deviations promptly and effectively.

•  Review and approve change controls related to deviations.

•  Review, change, and approve SOPs and other GMP documents as needed.

•  Act as the SME and Trainer for the Investigation/CAPA QMS module.

•  Participate actively in internal and external audits as a SME for deviations.

•  And execute other duties/tasks as assigned.

•  Bachelor's degree in Engineering, Chemistry, Biology, or related scientific discipline. Advanced degree preferred.

•  Minimum of 8-10 years of experience in pharmaceutical manufacturing, quality management systems, conducting investigations, enacting root cause analysis regarding deviations, and supporting QMS processes.
•  Experience with electronic quality management systems (MasterControl).

Job Summary:

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 cGMPs, 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
• Must have excellent attention to detail.

Physical Requirements:

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

Prolonged periods of standing.