Associate Scientist, QC Chemistry Full-time

Quality Assurance And Control

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.

Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.

At a minimum, the individual should be considered able to demonstrate the following:

• Acts safely and follows all EH&S safety requirements for site and QC laboratories
• Sufficient depth of knowledge within their scientific discipline and previous area of experience
• Good written and verbal communication techniques
• Ability to follow written procedures and learn from hands on training
• Capability of solving complex mathematical and situation dependent problems
• Ability to receive feedback and take accountability for actions and personal development
• Aptitude for good decision making based on procedures, guidance, and experience
• Awareness to know their own limitations and seek senior scientist or management guidance when appropriate
• Desire to ensure correctness and accuracy in tasks and documentation
• Fitness of functioning as a team member and performing independent work with minor guidance
• Willingness to use personal skills and knowledge to achieve individual and company goals and objectives
• Understanding of own area of function and knowledge of other cross functional areas
• Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
• Understands the importance of feedback and receives feedback well from management and other colleagues
• Makes good decisions based on knowledge of quality systems and technical experience
• Recognizes the impact of procedural changes that may impact future quality tasks and decisions
• Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations
• Responsible for personal timelines and seeks advice if conflicts arise
• Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines
• Ability to communicate effectively with good interpersonal skills

How You Will Achieve It

• Performs testing including, but not limited to, clinical product, commercial product, raw materials, and validation samples.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness, and compliance.
• Creates, reviews and approves GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) while ensuring adherence to Pfizer standards, guidelines and values.
• Reports issues to management and participates in issue resolution, such as reporting OOS results, participating laboratory investigations, reporting instrument issues, troubleshooting instruments, etc.
• Assesses existing situations and suggesting improvements to increase compliance and innovation.
• May perform data trending activities and assist with metrics reporting.
• May initiate and develop project plans to ensure projects timely completion.
• May serve on cross functional teams to facilitate communications between Quality Control and other departments.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
• Fundamental understanding of laboratory instrumentation function and analytical testing and use of analytical equipment.
• Aptitude for good decision making based on procedures, guidance, technology, and experience
• Effective communication skills
• Knowledge of Microsoft Office applications, specifically Word and Excel

Bonus Points If You Have (Preferred Requirements)

• A deep understanding of Chemistry testing and experience in defending laboratory practices during regulatory audits
• 2+ years of QC Chemistry Laboratory experience
• 1+ years of HPLC experience
• Proficiency in both viable and non-viable environmental monitoring within pharmaceutical manufacturing
• Solid grasp of aseptic techniques
• Strong problem-solving skills
• Computer programing knowledge
• Ability to work independently and as part of a team
• Ability to manage multiple tasks simultaneously

Physical/Mental Requirements

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

Non-Standard Work Schedule, Travel or Environment Requirements

• Work schedule 4 days a week 10 hours each day. Sunday to Wednesday (8:30 am to 7:00pm) but can include other weekdays and/or weekend days as appropriate for assigned tasks/activities Minimal off-shift work to ensure business needs are met.
• Not expected to travel.
• Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)

Work Location Assignment: On Premise

The annual base salary for this position ranges from $58,500.00 to $97,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.