Sr. Quality Control Specialist

2 weeks ago

Philadelphia, United States Planet Pharma Full time
  • 6-month contract to hire
  • Pay rate range is $62.31-$66.44/hr.
  • Fully onsite in Philadelphia, PA.
  • Mon-Friday 8a-5p - some weekend coverage


Top 5 Skills

  1. Quality Control Expertise: At least 5 years in the biopharmaceutical sector.
  2. Regulatory Proficiency: Solid experience with OOS investigations, deviations, change controls, and CAPAs.
  3. Educational Foundation: Bachelor’s degree and 5+ years’ experience, preferably with cell/gene therapy products.
  4. Investigative Analysis: Extensive QC/QA background in lab investigation reviews and change control documentation.
  5. Vendor Collaboration: Proven track record of managing external partnerships.


Overview

The Senior Quality Control Specialist - External Operations is responsible for the review of the executed test methods and raw data for lot release. This role must have a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to: Lot release; Method qualification and validation, Technology Transfers, and writing/review of QC procedures. Experience working in a GMP-regulated environment is essential, including knowledge of health authority expectations for novel and complex oncology programs. This position will require the candidate to be on-site at either their manufacturing CMO or their integrated Cell Therapy Center.


Essential Functions and Responsibilities

  • Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
  • Performs review and approval of CMO/CTL change controls.
  • Performs data analysis of CMO release testing to support product lot release with adherence to turnaround times.
  • Issue and write change controls and CAPAs when required.
  • Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
  • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents.
  • Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
  • All duties are performed with minimal supervision and oversight.
  • Performs other duties as assigned.


Required Education, Skills, and Knowledge

  • Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
  • Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
  • Must have experience with OOS investigations, deviations, change controls and CAPAs.
  • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
  • Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
  • Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)
  • Extremely detail-oriented with strong analytical, written, and verbal communication skills
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • Demonstrate sense of urgency; ability to recognize time sensitivity.
  • Flexible and adaptable style with an eagerness to take on challenges.
  • Problem solver who not only identifies issues but leads efforts to resolve them.
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • Successfully interface with multi-disciplined teams
  • High level of ownership and accountability.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Preferred Education, Skills, and Knowledge

  • Bachelor’s degree with 5 years of relevant experience with cell therapy products is a plus.

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