QO Technical Associate II

Pfizer • Kalamazoo, MI

7d • Onsite

About The Position

Pfizer is seeking a QO Technical Associate II to join their team. In this role, you will contribute to team deliverables, manage personal time and development, and follow standard procedures to complete tasks. You will identify and solve moderately routine problems with moderate supervision. The position operates efficiently in a fast-paced, customer-oriented team environment, providing support to Operations partners. Responsibilities include completing training, maintaining records and equipment in compliance with Current Good Manufacturing Practices (GxP), and participating in laboratory investigations. The candidate will conduct microbiological environmental sampling in aseptic/classified processing areas to support high through-put pharmaceutical manufacturing. This includes providing real-time feedback within the scope of the Aseptic Observations program, ensuring good documentation practices, and collaborating with others for compliance. The role also involves assisting in the overall operation of the microbiology laboratory, including sample incubation, result readout, and data entry into an electronic database. You may also second check records and assist in training others. You will interpret and evaluate data for accuracy, precision, trends, and potential Good Manufacturing Practices (cGMP) impact, recommending corrective actions as needed. Adherence to safe work practices, including wearing appropriate personal protective equipment (PPE) and aseptic gowning procedures in production areas, is required. You will perform equipment verification and calibration, and maintain the area and equipment in clean, safe, and functional order. Primary responsibilities include environmental sampling and Aseptic Observation in aseptic/classified processing areas, setting up sampling materials, data summaries in a computerized database, incubating samples, interpreting, and documenting results. You will recognize atypical data and inform supervision of relevant problems, enter, review, and approve data in a computerized database, and transport samples and supplies. The role requires applying technical knowledge of microbiological principles, theories, concepts, and Pfizer processes and industry practices/standards to daily work. You will work both independently and as part of a team, operating within established Px policies and basic colleague relations guidelines, and contributing to team objectives and project milestones.

Requirements

• High School Diploma or GED with 2+ years of relevant experience
• Basic math and computer skills such as data entry
• Understanding of equipment, instrumentation, and computer applications
• High productivity and the ability to multi-task
• Ability to read, comprehend, and follow procedures
• Good oral, written, and interpersonal communication skills within a diverse team setting
• Experience in a GMP environment
• Must be capable of maintaining aseptic gowning qualification in a production environment.
• Must be capable of manual manipulations with fine dexterity.
• Must be capable of walking for extended periods, bending, reaching and lifting (less than 35 lbs.) during routine job activities.
• Extended time working at a computer terminal could be required.
• Permanent work authorization in the United States.

Nice To Haves

• Quality Control experience
• Strong problem-solving and analytical skills
• Ability to work independently with moderate supervision
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

Responsibilities

• Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.
• Manage personal time and professional development, being accountable for results.
• Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.
• Identify and solve moderately routine problems.
• Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.
• Operate efficiently in a fast-paced, customer-oriented team environment, providing support to our Operations partners.
• Complete training activities, maintain records, equipment, basic lab supplies in compliance with Current Good Manufacturing Practices (part of GxP) requirements.
• Participate in laboratory investigations.
• Conduct a variety of microbiological environmental sampling in aseptic /classified processing areas using standardized procedures.
• Provide real-time feedback/guidance within the scope of Aseptic Observations program.
• Assist in the overall operation of the microbiology laboratory including incubation of samples, read out of sample results and entry of results into an electronic database.
• Second check records and assist in training others.
• Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices (cGMP) impact and recommend appropriate corrective action where necessary.
• Adhere to safe work practices, such as wearing appropriate personal protective equipment including lab coat, safety glasses, and gloves.
• Adhere to gowning procedures and practices (i.e. aseptic gowning) in production areas.
• Perform equipment verification and calibration in accordance with procedures.
• Maintain area and equipment in clean, safe, functional order.
• Set up sampling materials and data summaries in a computerized database.
• Incubate samples, interpret, and document results.
• Recognize atypical data and inform supervision of relevant problems.
• Enter, review, and approve data in a computerized database.
• Transport samples and supplies between the laboratory and production environments.
• Apply technical knowledge of microbiological principles, theories, concepts, and Pfizer processes and industry practices/standards to daily work.
• Be able to work both independently and as part of a team.
• Operate within established Px policies and basic colleague relations guidelines.
• Contribute to the completion of specific team objectives and assigned project milestones.

Benefits

• Eligibility for overtime, weekend, and holiday pay premiums
• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED