QC Potency Analyst

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

QC Potency Analyst

Cpl in collaboration with Pfizer is seeking QC Potency Analysts to join the team at Grange Castle site.

Pfizer Grange Castle, known for being one of the largest biopharmaceutical plants globally, is actively engaged in producing the Covid-19 vaccine. With a significant investment in our manufacturing facility, a range of new roles are being created within our organization. The Grange Castle facility is now geared up to produce the mRNA drug substance, making it a pivotal part of our network.

If you possess relevant experience in Quality Control Potency/Bioassay, this opportunity is perfect to be part of our journey in manufacturing and testing groundbreaking products that impact patients' lives.

The QC Potency/Cell Culture team is expanding, and analysts who join us will be responsible for maintaining regulatory compliance through established programs for laboratory testing, training, maintenance, and SOPs.

Job Responsibilities:

  • Execute cell-based assays including Potency bioassays, In-Vitro Expression assays, In-Vitro relative antigenicity assays, and ELISA.
  • Conduct various cell-based assays such as Gene Expression, Apoptosis, Proliferation, Antibody-dependent cellular cytotoxicity, among others.
  • Undertake tasks like cell counting, seeding, and passaging/maintenance.
  • Ensure timely completion of documentation related to analytical results.
  • Participate in laboratory investigations and corrective action tasks.
  • Review assay documentation and analytical results.
  • Maintain safe operations, attention to detail, and good documentation skills as per cGMP.
  • Perform routine Potency & Cell Culture tasks along with lab housekeeping.
  • Prepare media, qualify critical reagents, and handle waste.
  • Assist in training programs and training of other analysts.
  • Ensure adherence to established 5S process and contribute to continuous improvement projects.
  • Contribute to the development, review, and maintenance of SOPs for cGMP lab test procedures.
  • Work towards the Quality Goals for the department and lab.

Education/Experience:

  • Minimum of 1 year of relevant experience in a QC Potency role.
  • Demonstrated ability to work independently and as part of a dynamic team in a fast-paced environment.
  • Strong troubleshooting and problem-solving skills.
  • Experience with Labware LIMS, SoftMax, and Flow Cytometry is a plus.
  • Excellent organizational skills with a knack for seeing tasks through completion.
  • Outstanding communication and interpersonal abilities.
  • Keen attention to detail.
  • Willingness to work extended days shift if needed.

Additional Detail:

  • Legal eligibility to work in Ireland for the duration of a permanent contract is a prerequisite for this position.
  • Pfizer upholds equal employment opportunity principles and adheres to relevant legislation in all operating jurisdictions.
  • Due to the high volume of applications, only successful candidates will be contacted.
  • No relocation assistance is provided.

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