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QA Specialist II

QA Specialist II

ProclinicalPhiladelphia, USA
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QA Specialist II - Contract - Philadelphia, PA

Proclinical is seeking a QA Specialist II for a contract role based in Philadelphia, PA. This position focuses on quality assurance activities within the pharmaceutical and immuno-oncology space.

Primary Responsibilities :

The successful candidate will play a key role in ensuring compliance with regulatory standards, supporting manufacturing operations, and contributing to quality improvement initiatives.

Skills & Requirements :

  • Experience in scientific laboratory and / or production environments.
  • Knowledge of FDA GLP / cGMP requirements and PTC guidelines.
  • Familiarity with EU cGMPs and MHRA Out-of-Specification guidance is a plus.
  • Proficiency in root cause analysis techniques.
  • Experience with writing, reviewing, and approving laboratory investigations, deviations, and CAPAs.
  • Strong computer skills, including Microsoft Word, Excel, and Access.
  • Ability to perform accurate calculations and record data legibly.
  • Effective verbal and written communication skills.
  • Team-oriented with strong interpersonal skills.
  • Bachelor's degree in a science-related field or equivalent experience.

The QA Specialist II's responsibilities will be :

  • Review and approve non-conforming events (NCE) and CAPAs.
  • Conduct pre-review and approval of pre-executed batch records for assigned clients.
  • Perform post-review of manufacturing (MFG) batch records as needed.
  • Review and approve MFG Certificates of Analysis (COAs).
  • Timely review of complex study files, including assay and process validations.
  • Stay updated on GXP changes, including FDA, EU, and other regulatory guidance documents (e.g., ICH, ISPE).
  • Collaborate with manufacturing management to provide quality perspectives on routine operations.
  • Ensure project requirements are effectively translated into manufacturing records.
  • Work with document reviewers to compile and review raw data, batch records, and test results.
  • Investigate and explain observations or deviations as necessary.
  • Write and revise Standard Operating Procedures (SOPs).
  • Review and approve document change requests.
  • Oversee equipment validation (IQ, OQ, PQ) and change control processes.
  • Participate in quality and process improvement initiatives.
  • Coordinate and execute manufacturing suite inspections.
  • Support internal audits, client audits, supplier audits, and regulatory inspections.
  • Act as a point of contact for on-site client visits and audits.
  • Collaborate with project teams to design, set up, and execute projects.
  • Facilitate timely and accurate completion of pre- and post-executed batch records.
  • Contribute to departmental goals and overall operations.
  • Perform job-specific tasks in compliance with applicable regulations and internal policies.
  • Other duties as assigned.
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    Qa Specialist • Philadelphia, USA