Microbiology, Sterility and Lungworm Senior Technician
1 month ago
Job Description
We a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
In this role, you will provide technical and practical expertise for Microbiology and Sterility test methods to our QC labs in the UK and collaborate with other sites globally. You will be integral in supporting different functions on site for investigations, troubleshooting, change, and CAPA implementation related to aseptic manufacture and monitoring.
Responsibilities:
- Perform and oversee testing of all samples submitted to the micro and sterility department, including EM, water, intermediate, and finished products, in accordance with GMP, dossier, quality guidelines, and relevant pharmacopoeia requirements.
- Train new staff and provide ongoing training for staff in new or improved methods, ensuring training documents are up to date.
- Identify and facilitate Continuous Improvement opportunities to improve productivity and result in cost savings.
- Drive change management for the introduction of new/improved methods and validate new equipment and biomaterials.
- Chair Environmental monitoring meetings and author Environmental monitoring trend reports.
- Release batches in accordance with LROT and LTA, escalating any potential supply affects.
- Provide required data for Product Quality Reviews.
- Update SOPs and specifications to ensure they are current and relevant.
- Ensure timely completion of results in SAP and up-to-date specifications for microbiology lab tests.
- Lead complex investigations for out-of-specification and out-of-trend test results, identifying root causes and initiating appropriate CAPA actions.
- Support lab leads in successful CAPA completion and verification, including training staff in new/improved test methods.
- Adhere to QMS commitments and timelines, such as CAPAs, change controls, and deviations.
- Offer support to Production for manufacturing issues related to QC testing.
- Act as a health and safety representative for QC, participating in departmental safety meetings and promoting safety within the laboratory areas.
- Assist in preparing the schedule for the Microbiology/Sterility Lab and arranging coverage for weekends and holidays.
- Support Procurement and QA with changes related to external suppliers of test materials and critical consumables.
Qualifications and requirements:
- Bachelor's degree or higher in Microbiology, Biotechnology, or a related field.
- Experience in Microbiology and Sterility testing within the pharmaceutical or healthcare industry.
- Strong knowledge of GMP, dossier, and relevant pharmacopoeia requirements.
- Excellent problem-solving and troubleshooting skills.
- Ability to train and mentor staff in new or improved methods.
- Strong project management and change management skills.
- Attention to detail and commitment to quality and compliance.
- Excellent communication and collaboration skills
The above list of duties is not exhaustive and is subject to change. The post holder may be required to undertake other duties within the scope and grading of the post.
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:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/31/2024*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.
Job Posting End Date: 05/31/2024
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.
Requisition ID: R296602
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