Laboratory Quality Analyst
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.
Under the direction of the Associate Director, the Laboratory Operations Quality Analyst is responsible for enabling efficient execution of material testing for Merck’s Manufacturing Division in a safe and compliant manner, thereby contributing to the Merck’s ability to supply product to patients. The analyst will take ownership of several analytical assays, including communication with laboratory managers, product stakeholders and support groups. Specific duties may include the following:
- Responsible for the activities involved in conducting testing of validation, raw material, process intermediates and finished product samples, and is knowledgeable in the analytical techniques for the laboratory(s) they support.
- Responsible for the performing developmental testing, being knowledgeable of cGMP, company personnel policies, OSHA requirements and company safety procedures. Promotes teamwork and open communication.
- Act as a resource and liaison between Laboratory Operations and support groups to represent the needs of the laboratory.
- Responsible for performing lab work accurately and in a timely fashion. Responsible for critically evaluating data generated and recommending acceptance or rejection of samples.
- Responsible for updating SOPs, Process Specific Training Modules, Test Methods, etc.
- Required to facilitate relationship with Quality Assurance group
- Initiate and follow-up on equipment repairs and follow-up on facility work orders for laboratory modifications
- Represent the laboratory in various Safety and Compliance initiatives, including safety inspections
- Maintain records, develop productivity improvement plans, maintain adequate inventory of supplies, training records, tracking functions such as corrective actions, special projects, etc.
- Supports deviation investigations, out-of-trend results, and test failures associated with product manufacture, release testing, and stability testing.
- Responsible to improve laboratory quality and/or efficiency of assays, support regulatory inspections and train other Laboratory Operations assigned scientist and/or managers and laboratory technicians as required in new methods and procedures.
- B.S/B.A.in Microbiology or Biology with relative Microbiology course work.
- Minimum of (3) years’ post-degree laboratory, manufacturing, or quality control experience.
- Working knowledge of cGMPs
- Deep familiarity of laboratory methods and common instrument requirements for a laboratory
- Must possess strong communication, project management and problem-solving skills
- Demonstrated ability or aptitude for continuous learning and analytical problem solving.
- Customer service mentality and process improvement experience
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: Quality Lab Related
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck