QC Senior Scientist
- United States - North Carolina - Sanford
Use Your Power for Purpose
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.
What You Will Achieve
In this role, you will:
- Acts safely and follows all EH&S safety requirements for site and QC laboratories.
- Be recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards.
- Excellent written and verbal communication skills
- Ability to identify issues, present complex problems with possible solutions, and actively take a leadership role to resolve issues.
- Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information.
- Ability to receive feedback from management and colleagues 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.
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
- Able to create, review, and approve compliant test methods and training materials.
- Perform tasks associated with maintaining Current Good Manufacturing Practices (part of GxP), compliant Quality Control, and Stability laboratories.
- Support preparation of reagents, receipt, storage and handling of reagents.
- Perform testing including but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
- Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
- Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
- Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects.
- Perform various inspections of laboratories and surrounding office area as assigned and prepare a report.
- Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
- Train junior colleagues and may develop training plans and/or oversee training activities for groups.
Here Is What You Need (Minimum Requirements)
- Applicant must have a Bachelors with at least 9 years of experience OR Masters with more than 7 years of experience or a PhD with 0+ years of experience.
- Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
- Fundamental understanding/use of laboratory instrumentation function and analytical testing focused on analytical methods (e.g. HPLC/UPLC, iCIEF/Maurice, Purity/PA800+, plate-based methods)
- Experience with Laboratory Information Management System (LIMS) and Data review
- Aptitude for good decision making based on procedures, guidance, and experience.
- Effective communication skills
- Knowledge of Microsoft Office applications, specifically Word and Excel
- Excellent effective written and verbal communication and interpersonal skills
- Ability to work in a team environment.
Bonus Points If You Have (Preferred Requirements)
- Experience defending laboratory practices in regulatory audits and Quality Operations
- Relevant experience in biotherapeutics (antibodies, vaccines, and gene therapy)
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 is first shift (8:00 am to 4:30 pm) but can include weekdays and/or weekend days as appropriate for assigned tasks/activities. Minimal flexibility in work schedule to cover business needs. Minimal off-shift work to ensure business needs are met.
- Non-existent to minimal travel.
- Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)
- Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: April 14, 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.