QA Manager, Investigation Review

Pfizer • Sanford, NC

94d • $96,300 - $160,500

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. You will be a member of Pfizer's dedicated and highly effective quality assurance team. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations to ensure compliance with configuration management policies.

Requirements

• High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with 8 years of experience; OR a Bachelor's degree with at least 5 years of experience; OR a Master's degree with more than 3 years of experience; OR a Ph.D. with 0+ years of experience.
• Pharmaceutical manufacturing/Quality experience.
• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes.
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems.
• Expertise with investigation of complex technical issues.

Nice To Haves

• Knowledge or exposure to data sciences.
• Experience with Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Veeva Vault; Systems, Applications, and Products (SAP).
• Experience in conducting internal audits and supporting regulatory inspections.

Responsibilities

• Have sufficiently broad depth of knowledge of GXPs to be a key contributor or may be able to lead continuous improvement to a process or improve business efficiencies.
• Identify and implement new processes and programs for quality improvement.
• Contribute to the interpretation of cGXPs for the commercial and clinical environment.
• Independently review working instructions/global procedures for technical content across multiple subject areas, with reference to applicable GXPs and regulatory expectations making value-added comments.
• Interface with other parts of the organization such as Pfizer research and development groups.
• Resolve complex issues with minimal assistance from management.
• Represent Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
• Review trending reports and influence/agrees actions with key stakeholders.
• Provide guidance/coaching to less experienced colleagues.
• Interpret and understand complex data and form conclusions and next steps based on findings with minimal assistance from management.
• Advise on more complex policy and procedures.
• Make decisions that may involve complex quality and technical issues.
• Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas.
• Coach/mentor other colleagues during the investigation process.
• Collaborate/independently engage with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
• Anticipate issues and elevate them to appropriate management attention immediately.
• Demonstrate sound judgment on decisions that may involve technical issues.
• Assess internal and external compliance with applicable regulations.
• Train colleagues on workgroup practices within area of expertise.
• Proactively and independently apply departmental best practices to work assignments.
• Recognize when a multi-disciplinary discussion/issue is beyond their sphere of influence and escalate accordingly.
• Routinely demonstrate a good practice of technical exchange and open communication with team members.
• Participate in and may take a lead in decision making process.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree