QC Bioanalytical Specialist
QC Bioanalytical Specialist
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Job Description
Job Description
An amazing opportunity has arisen for a QC Bioanalytical Specialist at our Biotech Dublin site. The role will report to the QC Bioanalytical Manager. The QC bioanalytical analyst will lead laboratory investigations and be the subject matter expert for change controls on site with strong communication skills you will collaborate with different departments and work on various projects. The QC Bioanalytical team is primarily responsible for the testing of Raw Materials Chemistry Bioassay DNA and Stability samples.
What you will do:
Bring energy knowledge innovation and leadership to carry out the following:
- Lead technical Laboratory Incidents Investigations and Problem Solvings.
- Support routine analytical testing with assays such as HPLC CE UV Compendial PCR and ELISA techniques on Release In-process Raw Materials and Stability samples.
- Lead local change controls and participate as a laboratory SME for changes in the network which impact the laboratory.
- Author Review and Approve technical writing activities such as Protocols Reports and procedures.
- Participate and lead Continuous improvement and Laboratory transformation projects.
- Support Divisional Regulatory and EHS audits as an SME in your area on site.
- Play a key role in the troubleshooting and escalation process on site.
- Calibrate and maintain all designated laboratory instruments.
- Follow up-to-date practices with reference to pharmacopoeias specifications regulations and industry standards.
- Ensure training is current for all job functions performed.
- Maintain data integrity and ensure compliance with company SOPs specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Promote and participate the implementation and maintenance of the relevant safety programmes.
- Maintain MPS/Lean Lab standards within the laboratory.
- Support with various QC related Initiatives.
- Maintain good housekeeping and hygiene within the laboratory.
In order to excel in this role you will need:
- Bachelors degree (or higher) in Natural Science/Chemical Engineering/Biological Engineering.
- Minimum 4-7 years experience in the pharmaceutical industry.
- Experience in performing Laboratory testing with a good understanding of relevant Analytical techniques.
- Experience in Technical writing (Investigations Procedures Change Controls etc.).
- Project participation and leading experience.
- Experience in participating in audits as an SME (Subject Matter Expert).
- Working knowledge of Six Sigma and Lean methodologies.
- Knowledge of GMP practices.
- Working knowledge of ICH guidelines and global pharmacopeial requirements.
- Experience using laboratory software (Empower 3 LIMS SAP etc.).
As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So if you are ready to:
Invent solutions to meet unmet healthcare needs Impact the future by driving one of the worlds leading healthcare companies and inspire your team to reach their full potential and push the boundaries of science and technology please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Biochemical Analysis Change Controls Deviations Documentations Enzyme Linked Immunosorbent Assay (ELISA) IS Audit Laboratory Testing Polymerase Chain Reaction (PCR) Regulatory Compliance Six Sigma Technical WritingPreferred Skills:
Job Posting End Date:
08/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
