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Pfizer · 6 days ago

Sr. Associate - QA Operations

St. Louis, MO

Full-time

Hybrid

Mid, Senior Level

$80K/yr - $134K/yr

2+ years exp

Pfizer is committed to delivering safe and effective products to patients, emphasizing a quality culture that prioritizes patient care. The Sr. Associate in QA Operations will provide oversight to GMP manufacturing and testing operations, ensuring compliance and quality throughout the production process.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

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

Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs

Perform quality assurance disposition function for raw materials, in-process solutions, and/or production batches

Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness

Participate on technology transfer teams reviewing and approving master batch records and related documentation

Support the site relative to a constant state of inspection readiness

Participate in audits relative to this role as needed

Make quality decisions to resolve moderately complex issues with minimal assistance from management

Recognize when an issue is beyond their sphere of influence and escalate immediately

Present to peers/management locally or electronically

Contribute to quality assurance management team initiatives and objectives

Provide review of equipment/instrument validation documentation and related calibration documentation, as needed

Participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance

Participate in quality risk management activities

Assist in the process of gathering, interpreting and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations

Assist in the review of area documentation and perform trend analysis on data, controls and standards

Responsible for knowing, understanding and acting in accordance with Pfizer’s values

Demonstrate strong interpersonal, teamwork, and collaboration skills

Qualification

Quality AssuranceCGMPStatistical SoftwareAuditingTechnical WritingAnalytical SkillsProblem-SolvingInterpersonal SkillsTeamworkCommunication Skills

Required

Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes

Understanding of cGMP, Data Integrity

Strong understanding of Quality System functions, manufacturing and/or packaging processes

Excellent technical writing, communication, and presentation skills

Proficiency in Microsoft Office, Microsoft Project, and Statistical Software

Experience in preparing and participating in audits and inspections