Laboratory Manager Quality Control-QUA005856
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. 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.
Under the direction of the Associate Director, the Laboratory Operations Manager 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 manager will take ownership of several analytical assays, including communication with laboratory technicians, 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 supervision of hourly employees performing testing. Includes scheduling of work assignments based on priorities, being knowledgeable of cGMP, administration of local bargaining agreement, company personnel policies, OSHA requirements and company safety procedures. Promotes teamwork and open communication.
- Act as a resource and liaison between technicians 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 managers and/or technicians.