Production Technician
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.
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 person…
Senior Quality Investigator
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).
• Advanced Knowledge of cGMP regulations, preferably related to pharmaceutical manufacturing. • Strong capability to conduct thorough root cause analysis and applying structured problem-solving techniques. • Leadership and organization, resolving conflict and meeting deadlines. • Excellent verbal and written communication skills. • Ability to work collaboratively to accomplish deadlines and objectives. • Ability to write procedures and reports clearly and accurately. • Ability to be proactive and adaptable to changing priorities. • Ability to prioritize tasks and manage multiple projects simultaneously in a dynamic environment. • Ability to mentor and train other team members to achieve proficiency. • Strong critical thinking and problem-solving skills to address complex issues and challenges. • Proficiency with Microsoft Applications, including MS Word, Excel, and Teams. |
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 …
Quality Control Technician
STAQ Pharma is currently hiring for a quality control technician to join our team here in Columbus
STAQ Pharma:
- Safety, Transparency, Availability, and Quality.
- FDA Registered 503B Outsourcing Facility that produces sterile injectable medications for adult and pediatric patients, compounded under Current Good Manufacturing Practices (cGMP) standards.
- Facilities in Columbus, Ohio and in Denver, Colorado.
- Regulated by the FDA, DEA, and all State Boards of Pharmacy.
Summary
Quality Control Technician is responsible for: - Ensuring compliance with cGMP requirements and company procedures.
- Providing QC Support throughout all departments.
- Coordinating QC sample preparation and external laboratory shipments.
- Assisting with Environmental Monitoring activities.
Roles and Responsibilities - Maintain retention materials and disposal when required.
- Assist with review and release of raw materials, API, excipients, and sterile supplies.
- Coordination of Biohazard waste destruction.
- Perform sampling and inspection of in-process and finished products.
- Assists with Environmental Monitoring activities.
- Logbook and controlled document generation.
- Assist with investigations and develop and implement corrective and preventive actions geared toward continuous process improvements.
- Review GMP documents including master batch production records, room and equipment logs, etc.
- Support quality management system activities including document control and training program management.
- 1-3 years as a Quality Technician.
- Other duties and tasks, as assigned.
Qualifications and Education Requirements
Must be able to read and write in English - Pharmaceutical, Medical Device industry, or biotechnology experience, preferably in support of manufacturing.
- Associate degree in the sciences or equivalent experience preferred.
Preferred Skills - Excellent independent judgement, written communication, verbal communication, and interpersonal skills.
- Strong attention to detail.
- Familiarity with Good Manufacturing Practices and FDA Regulations.
- Proficient in using Microsoft Word, Excel, PowerPoint, Outlook.
Additional Notes
This position will work closely with the Production team and report quality data to department management, as needed.
STAQ Pharma is currently hiring for a quality control technician to join our team here in Columbus STAQ Pharma:
STAQ Pharma is currently looking for quality assurance technician for their facility located in the Denver Metro area – join a team that values it\’s team members and encourages the growth and success of all!
1st Shift:
Pay: $20-$22/hour
Schedule: Monday to Friday, 6 AM to 2:30 PM
Your responsibilities include:
- Print and maintain control of product labels
- Perform sampling and inspection of in-process and finished products
- Assist with investigations and develop and implement corrective and preventive actions geared toward continuous process improvements
- Perform evaluations to determine effectiveness of corrective actions
- Review GMP documents including master batch production records, room and equipment logs, etc.
- Support quality management system activities including document control and training program management
- Provide supplier related support to production and receiving inspection team
Qualifications:
- 1-3 years as a Quality Technician
- Must be able to read and write in English
- Pharmaceutical or Medical Device industry or biotechnology experience, preferably in support of manufacturing
- Associates degree in the sciences or equivalent experience preferred
Benefits:
Medical, Dental, Vision, 401K, flexible PTO plan, FSA, HSA, Short & Long Term Disability, Pet Insurance & Mental Health Support!
STAQ Pharma:
- Safety, Transparency, Availability, and Quality.
- FDA Registered 503B Outsourcing Facility that produces sterile injectable medications for adult and pediatric patients, compounded under Current Good Manufacturing Practices (cGMP) standards.
- Headquartered in Denver, Colorado and an additional facility in Columbus, Ohio.
- State-of-the-art facilities and commitment to automation for preparation of ready to administer pharmaceutical products in syringes, pumps, bags, etc.
- Regulated by the FDA, DEA, and all State Boards of Pharmacy.
STAQ Pharma is currently looking for quality assurance technician for their facility located in the Denver Metro area – join a team that values it\’s team members and encourages the growth…
Production Associate 1
This position functions primarily in a controlled-non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will perform labeling, 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 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 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.Maintain a quality focused, “Right First Time”, attitude. |
Arrive for work on-time, prepared to work in the CNC 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 cGMP experience.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. Must be able to read and write in English |
This position functions primarily in a controlled-non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will perform labeling, visual inspection, and othe…