QC Potency/Cell Culture Analyst

Job Description

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitment tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.

You will be recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will train others and reinforce behaviours that will help us achieve our goal of providing the best to patients.

How You Will Achieve It

Execute testing for cell-based assays including Potency bioassays, In-Vitro Expression assays, In-Vitro relative antigenicity assays and ELISA.

Perform cell counting, cell seeding and cell passaging/maintenance.

Complete documentation associated with analytical results in a timely manner and in line with cGMP practices.

Peer review assay documentation and analytical results.

Facilitate and assist with laboratory investigations and corrective action tasks.

Perform media preparation.

Execute qualification testing of critical reagents.

Perform inactivation of biological waste.

Support the creation of new LIMS builds for new Cell Lines and Assays.

Generate and maintain working cell banks and inventory.

Support and assist in the introduction of new products and cell lines.

Assist in the maintenance and development of training programs and perform training of other analysts.

Maintain established 5S process and assist in the 5S audits and related activities.

Support and assist the continuous improvement projects and all related CI activities.

Follow and assist in the creation, review and maintenance of SOP's for cGMP lab test procedures and systems.

Contribute to the Quality Goals for the department/lab.

Education/Experience

• Third level qualification in Science, Engineering or equivalent.
• Minimum of 3 years' experience in QC.
• Bioassay and mammalian cell culture experience preferred.
• An ability to work independently, and as a member of a team in a dynamic, fast-paced environment that requires flexibility and initiative.
• Excellent trouble shooting and problem-solving skills
• Relevant Labware LIMS, SoftMax and Flow Cytometry experience desirable.
• Strong organization skills, including ability to follow assignments through to completion.
• Excellent communication and interpersonal skills.
• Proven high level of attention to detail.

Additional Detail

• Shift work may be required for this role.
• To be considered for this position you need to be legally eligible to work in Ireland for the length of a permanent contract.
• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
• Due to high volume of applications we will be contacting successful candidates only.
• We do not offer relocation.

  
Work Location Assignment: On Premise

  
All applicants must have relevant authorisation to live and work in Ireland.

 
 
Quality Assurance and Control