Quality Assurance Specialist (QA for QC)

Pfizer

22h • Onsite

About The Position

This position provides Quality Assurance oversight for Quality Control (QC) Department. 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. The role required to act independently supports process improvement and facilitates the implementation. How You Will Achieve It Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol, Technical documents, amongst others. Provide final QA approval on change control, compendial assessments, and other documents associated with the business unit. May also review and approve documents such as Deviation, contract laboratory investigation, and Non-conformance investigations associated to Protocol executions. Capable to Make quality decisions in real time according to regulations and procedures. Ability to work collaboratively with internal partners to resolve technical issues. Willing to perform other duties as assigned and take ownership to support the implementation of activities needed to support the business needs.

Requirements

• Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an Associate’s degree with 4 years of experience OR a Bachelor’s degree in Science or related field with 0 years of experience.
• Ability to be problem-solving and analytical skills.
• Knowledge of Pharmacopeia, Familiarize with Equipment Qualification and Regulatory Requirements.
• Attention to detail and the ability to work independently.
• Experience in Quality Control Laboratory cGMP’s Laboratory environment.
• Experience or background of applied statistics.
• Proven ability to work in a team environment through conflict resolution and negotiation.
• Provides excellent communication, writing, and analytical skills.

Nice To Haves

• Experience in manufacturing, laboratory, quality, technical or engineering experience within biotech of the pharmaceutical industry.
• Prefered experience in Quality Control Laboratory.
• Familiarized and experienced in Pharmacopeia requirements. (e.g., USP, JP, EMEA amongst others)
• Familiarization with the Data Integrity requirements.
• Experience such as deviations, Change Controls, Stability Protocols, and all the implementation activities.
• Support in CAPA closures, Effectiveness checks, and experience in Root Cause Analysis tools.
• Experience in a quality assurance role, preferably in Quality Assurance for a Quality Control role in the document such as: (e.g., OOS (Out of Specification), OOE (Out of Expectation), OOT (Out of Trend) investigation, specification, method transfer protocol, stability protocol, and others).

Responsibilities

• Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol, Technical documents, amongst others.
• Provide final QA approval on change control, compendial assessments, and other documents associated with the business unit.
• May also review and approve documents such as Deviation, contract laboratory investigation, and Non-conformance investigations associated to Protocol executions.
• Capable to Make quality decisions in real time according to regulations and procedures.
• Ability to work collaboratively with internal partners to resolve technical issues.
• Willing to perform other duties as assigned and take ownership to support the implementation of activities needed to support the business needs.

Benefits

• a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• 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: Entry Level