Specialist, Laboratory Quality Assurance
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations. The Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia). The Laboratory Specialist will also approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
The Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor. He or she will work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation. He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review. Additionally, the Laboratory Specialist will utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.
- Present on shop floor to provide compliance support and to learn testing procedures, analytical processes and Merck Quality Systems.
- Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
- Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
- Maintain metrics and tracking associated with these documentation reviews.
- Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
- Perform review and approval of qualification documents as needed.
- Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
- Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
- Responsible for issuance of new and reconciliation of completed laboratory worksheets.
- Foster a customer service attitude within Laboratory Operations.
- Review laboratory notebooks, logbooks and CTU records to ensure accuracy and data integrity compliance.
- Provide support to Regulatory Agency inspections as needed.
- Assist with training of new personnel.
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck