* Acts as a Laboratory subject matter expert for testing including but not limited to Bioassay, Immunoassay, Cell Culture and Aseptic Technique.
* Develop, implement and maintain procedures that comply with appropriate regulatory requirements
* Leads method transfers and provides technical expertise, trouble-shooting, training and support to laboratory analysts.
* Lead qualification of analytical equipment and related testing functions
* Ensures Quality Control readiness to support all scheduled activities, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
* Required to comply with Global Policies, Procedure and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Reporting to the Quality Operations Lab Lead the successful candidate will provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
* Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures
* Participate in the timely generation of trend data, investigations, non-conformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
* Manage and contribute to the achievements of department productivity and quality goals
* Represent the QC Department on site/inter departmental projects with Operations / Technical Engineering / Supply Chain as required.
* Represent the QC Department on above site forums as required.
* Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
* Bachelor degree in Biology, Biotechnology or related discipline
* 4-5 years of experience in a pharmaceutical Laboratory, preferably with in Bioassay lab
* A strong background in Bioassay, Immunoassay and Cell Culture is essential
Initial Travel Requirements:
* The successful candidate will be expected to travel to other sites within Europe or the US for approximately 3 months training.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists