QC Chemistry Associate Scientist

Pfizer • Sanford, NC

1d • Onsite

About The Position

The QC Chemistry Associate Scientist supports Pfizer’s Sanford, North Carolina Quality Operations department by performing Quality Control activities for clinical and/or commercial products, raw materials, validation, and stability. The role helps maintain compliant Quality Control and Stability laboratories and performs testing, analyzes and interprets results, trends data, and creates, reviews, and approves documentation.

The position requires working knowledge of laboratory practices, analytical testing and instrumentation, quality systems, and applicable GMP requirements. The individual must be able to follow procedures, apply sound judgment, maintain accurate documentation, solve mathematical and situation-dependent problems, work independently with minor guidance, and collaborate as a team member. The role also involves identifying issues, participating in resolution, and suggesting improvements to compliance and innovation.

The work is on premise in Sanford, North Carolina. The scheduled workweek is Wednesday through Saturday, 8:00 a.m. to 6:30 p.m., with possible work on other days, limited schedule flexibility to cover business needs, and minimal off-shift work. The employee must wear appropriate personal protective equipment.

Requirements

• 0–3 years of manufacturing, quality, or analytical testing experience in the biotech or pharmaceutical industry.
• A BS/BA degree in science or a related field with biotech or pharmaceutical industry experience is preferred; other appropriate combinations of education and/or relevant industry experience are suitable.
• Understanding of laboratory practices, analytical testing, and analytical equipment such as UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC, and conductivity.
• Understanding of laboratory practices, analytical testing, and laboratory equipment such as glass washers, autoclaves, and balances.
• Knowledge of current GMP, including US, EU, and rest-of-world cGMP requirements; pharmacopeias; ICH guidelines; analytical techniques and instrumentation; and LIMS.
• Knowledge of TrackWise, Microsoft Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; quality change control, investigations, and documentation systems; and Quality Risk Management, including risk assessments.
• Ability to lift 30 pounds; stand or sit for 2 to 3 hours at a time; walk long distances; and bend to retrieve items from lower shelves or cabinets.
• Ability to perform mathematical problems and complex data analysis.
• Ability to wear required PPE, including a lab coat, safety glasses, non-porous shoes, and gloves.
• U.S. work authorization by any employer; U.S. work visa sponsorship is not available.
• Ability to work the Wednesday-to-Saturday schedule, potentially on other days as needed, with limited schedule flexibility and minimal off-shift work.

Nice To Haves

• A BS/BA degree in science or a related field with experience in the biotech or pharmaceutical industry.
• Experience with manufacturing, quality, or analytical testing in the biotech or pharmaceutical industry.

Responsibilities

• Know, understand, and act in accordance with Pfizer’s values and OWNIT culture.
• Perform tasks associated with maintaining GMP-compliant Quality Control and Stability laboratories.
• Test clinical and/or commercial products, raw materials, and validation samples.
• Analyze and interpret results and make decisions about accuracy, completeness, and compliance.
• Create, review, and approve GMP documentation, including test records and, as assigned, validation protocols and reports, test methods, and equipment records.
• Report issues to management and participate in resolving them, including reporting out-of-specification results and participating in laboratory investigations, and reporting instrument issues and assisting with troubleshooting.
• Assess existing situations and suggest improvements to increase compliance and innovation.
• Handle complex investigations and associated CAPAs within the assigned work area under limited guidance.
• Detail requirements for LIMS builds and/or build and test new LIMS builds and LIMS Master Data changes.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Potential relocation assistance based on business needs and/or eligibility.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level