MSD QC Bioassay Analyst 

Ireland 

860835687

Job Description

R306281 QC Bioassay Analyst

QC Bioassay Analystyou will perform and review a range of techniques such as immunoassays, cell-based potency bioassays and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.

You will ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety, and reliable supply to our customers.

Reporting to the Bioassay Manager / Associate Director, the team is working a2-cycle shift patternof 7am-3pm and 3pm-11pm (Monday-Friday) rotating weekly.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
• Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Develop, implement, and maintain procedures that comply with appropriate regulatory requirements.
• Ensure that all Quality Systems within the department are adhered to daily.
• Operate as part of the QC team performing the allocated testing and laboratory-based duties.
• Ensure timely completion of all assigned data processing and reviewing.
• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.
• Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of methodvalidation/verificationsand equipment qualifications.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Where applicable, review, approve and trend test results.
• Participate in the laboratory aspects of OOS investigations.
• Provide support with audit/inspection requirements to ensure departmentcompliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

In order to excel in this role, you will more than likely have:

• Bachelor’s Degree or higher preferred; ideally in a science related discipline.
• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP.
• Laboratory Quality Systems experience.
• Proficiency in Microsoft Office and job-related computer applications
• Report, standards, policy writing skills
• Understanding of Lean Six Sigma Methodology preferred.
• Immunoassay and cell culture experience preferable.
• Great communicator, decisive decision-maker with a proven ability to deliver excellence.
• Ability to participate in highly effective teams.
• Desire to continuously learn, improve and develop.
• Willingness to support the team and a strong focus on delivering excellence.
• High personal integrity, credibility, energy, and flexibility.

please apply today.

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Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.