Sr Associate MQA 2nd Shift
Sr Associate MQA 2nd Shift
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$ 80300 - 133900
1 Vacancy
Job Description
Use Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and riskbased 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.
What You Will Achieve
The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical commercial and contract manufacturing operations providing QA Operations Floor oversight. The role ensures adherence to regulatory expectations safety and GxP (i.e. Current Good Manufacturing and Documentation Practices). Duties include but are not limited to Aseptic Observations Acceptable Quality Limit (AQL) testing batch record review line clearance approvals alarms evaluation on the floor triage and on the floor real time batch record review. The Senior Associate will work crossfunctionally with manufacturing and support groups to investigate manufacturing events and support site internal and external regulatory inspections. The role is based at the Pfizer Sanford NC Pfizer Global Supply (PGS) site and provides oncall after hours and weekend support to ensure no interruptions of 24/7 operations.
In this role you will:
The Manufacturing Quality Operations Senior Associate support includes documentation review facility walkthrough remediation/escalation of nonconformances deviations and other issues from the manufacturing floor including support for activities such as review of inprocess records AQL aseptic observations compliance walkthroughs smoke studies media fills alarms evaluation etc.
Assess manufacturing operations/documentation to ensure proper and adherence to Procedures Regulatory requirements Safety Quality Agreement requirements and Pfizer Quality Standards (PQS) expectations.
Work crossfunctionally with various business groups (i.e. Operations Tech Ops Automation Compliance Process Engineering Investigators etc. on manufacturing events to identify root cause(s) complete impact assessment and identify Corrective/Preventive Action (CAPA).
Represent QA in crossdepartmental/crosssite meetings. Aid in resolving and provide guidance/pathforward. Independently makes decisions with minimal assistance from QA management.
Support site regulatory inspections.
Facilitate internal & external meetings and provide training/presentations/updates/reportout to QA and Manufacturing colleagues on a regular basis.
Lead & suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the one best way philosophy.
Perform intermediate compound and final product batch record review/disposition using computer software applications including but not limited to: gLIMS SAP MES AMPS Batch Tracker.
Review/approve new/existing procedures (SOPs MBRs Job Aids etc. in Documentum/ PDOCS to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.
Provide guidance/coaching to less experienced QA and Manufacturing colleagues.
Assist with other tasks as needed such as: Internal Audits/Assessments Gap Analysis Regulatory Inspection Readiness.
Here Is What You Need (Minimum Requirements)
BA/BS degree in Microbiology Chemistry Biological Sciences Bioengineering (preferred) with 2 years of experience OR MBA/MS degree in Microbiology Chemistry Biological Sciences Bioengineering (preferred) with any years of relevant experience OR Associates degree in Microbiology Chemistry Biological Sciences Bioengineering (preferred) with 6 years of experience OR High school diploma (or equivalent) with 8 years of experience
Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry. Knowledge of and experience in a biopharmaceutical/pharmaceutical cGMP environment
Knowledge of electronic systems including Trackwise Documentum/PDOCs SAP gLIMS Microsoft Office.
Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements
Strong critical thinking skills
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Proactive approach to problemsolving
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
Physical / Mental requirements
Role requires ability to gown into the manufacturing areas standing work for several hours continuously.
NonStandard work schedule travel or environment requirements
Second shift: 3PM12AM
Other job details
Last day to apply: April 25th 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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Employment Type
Full-Time
