Associate Scientist, QC Chemistry

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 expe