Laboratory Manager

Job Title:

Laboratory Manager

Department:

Quality Control

Reports To:

Quality Control Director

Pay Classification:

Exempt

Position Summary:

Responsible for managing the Quality Control Unit in the execution of analytical laboratory tests and evaluations of product performance and processes, in accordance with approved methodologies, policies, and associated regulations.

Duties & Responsibilities include but are not limited to:
  • Interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Ensuring that department members are trained to comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
  • Implementing and maintaining the analytical testing program applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process.
  • Evaluating and justifying purchases of instrumentation/equipment required for performance of tests; initiating and implementing new test methods or conducting method transfer, as appropriate; and executing training of analysts/technicians on new methods of new technology.
  • Validating new methods and modifications to current methods, following regulatory advice for filing strategy before implementation on commercial production.
  • Scheduling laboratory workload to ensure timely completion of tasks.
  • Reviewing and maintaining laboratory data and records in accordance with company policies.
  • Maintaining/coordinating the product stability testing, environmental monitoring, and equipment/ instrument calibration programs.
  • Conducting and coordinating line clearance activities in support of manufacturing processes.
  • Assisting in the performance of quality inspections, audits of quality control programs, and/or internal compliance audits when appointed by the QA Manager/Director; serving in supporting role for many of the Quality Assurance systems (i.e. CAPA, Complaint Handling, Change-Control, Validation).
  • Independently performing and adequately documenting basic investigations for out-of-specification/out-of-trend results.
  • Providing assistance to the Laboratory Director; preparing and presenting staff reports and other necessary correspondence.
  • Providing support in the preparation of annual budget for assigned areas of responsibility.
  • Assisting departmental management in the execution/implementation of projects, as requested.
  • Serving in a leadership role on optimization teams and special project teams, as applicable.
Qualifications Required:
  • High school diploma at minimum, some college level courses or experience in a science related field preferred.
  • A minimum of 5 years of progressive management experience in a Quality Control environment, preferably in the pharmaceutical or medical device industry.
  • Must have a solid working knowledge of GMPs, and familiarity with In Vitro Diagnostic Device manufacturing, USDA, ISO, and OSHA regulations is strongly desired.
  • Must be proficient in MS Word and Excel.
  • Excellent written/oral communication and interpersonal skills are required.

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.