Sr. Quality Assurance Specialist
- United States - North Carolina - Sanford
Use Your Power for Purpose
Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
The position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation / QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Leads triage using trend activities. The role might need to act independently to help identify process improvement and facilitate the implementation.
What You Will Achieve
In this role, you will:
Work to develop and implement quality assurance procedures and guidelines to support the Quality Control team’s testing and evaluation efforts.
Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
Provide final QA approval on more complex change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
May also review and approve Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build Master Batch, or any electronic record when needed, and all associated with compendial changes.
Drives compliance, efficiency, and process improvement projects.
Capable to make complex quality decisions in real time according to regulations and procedures.
Interfaces with internal partners to resolve technical issues.
Perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
BA/BS degree in Biology, Chemistry, Micro and Bioanalytical with 2+ years of experience OR MBA/MS degree in Biology, Chemistry, Micro and Bioanalytical with any years of relevant experience OR Associate’s degree with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of experience.
Experience in Quality Control Laboratory (e.g., transfer, equipment qualification, analytical testing, stability, etc.) cGMP’s Laboratory environment (Pharmaceutical industry)
Familiarized and experience in Pharmacopeia requirements (e.g., USP, JP, EMEA amongst others)
Experience or familiarized with Data Integrity requirements
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills, problem solving and analytical skills
Attention to detail and ability to work independently
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Provide excellent communication writing and analytical skills
Bonus Points If You Have (Preferred Requirements)
Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues
Proven ability work in a team environment through conflict resolution and negotiation
Physical/Mental requirements
Ability to work in a fast-paced, dynamic environment
50% on the floor time (walking/standing)
Able to manage different priorities
Occasionally lift and or move object up to 30 pounds
Stand / walk during the entire length of the shift
Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus
Gowning is a requirement of this position as is the use of the other PPE (Personal Protective Equipment)
Non-Standard work schedule, travel or environment requirements
Regular Business hours or shift schedule
Other job details
Last day to apply: April 16th, 2025
No relocation support available
Employee Referral Bonus eligible
Work Location Assignment: On Premise
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.