Senior QC Laboratory Analyst

Job Title:

Senior QC Laboratory Analyst

Department:

Quality Control

Reports To:

Quality Control Manager

Pay Classification:

Non-Exempt, Hourly

Position Summary:

Responsible for execution of analytical laboratory tests and evaluations of product performance and processes in the Quality Control Department, in accordance with approved methodologies, policies, and associated regulations. Serves as witness and approver of test results obtained by Level I analysts

Duties & Responsibilities include but are not limited to:
  • Performing analytical laboratory tests applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process.
  • Generating and maintaining laboratory data and records in accordance with company policies.
  • Assuring that product stability testing is being conducted in accordance with defined schedules and updating the long term stability master list.
  • Assuring that product expiry testing is being conducted in accordance with defined schedules.
  • Executing requirements for the environmental monitoring and equipment monitoring programs
  • Participating in the validation of new methods and modifications to current methods.
  • Independently performing and adequately documenting basic investigations for out-of-specification/out-of-trend results
  • Assisting in the Training of Level I analysts
  • Supporting RA and QA in the complaint handling process through testing and evaluation of retained product and returned goods, as requested
  • Reviewing and approving test results and associated data records for Level I analysts, under the direction of the QC Manager
  • Scheduling the laboratory workload to ensure timely completion of tasks
  • Maintaining an inventory of lab supplies and filling out Purchase Requests and Inventory Adjustment forms for QC Manager Approval as needed.
  • Assisting in lateral communications to aid in assessing priorities and streamlining daily activities
  • Performing line clearance activities when requested by QA in support of manufacturing processes
  • Assisting departmental management in the execution/implementation of projects, as requested.
  • Complying with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
Qualifications Required:
  • B.S. degree in biology, microbiology, or a related discipline preferred; at minimum, high school diploma required with some college level courses or experience in a science related field.
  • Experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industry with knowledge of GMPs or ISO regulations is 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 and salary requirements to srivera@chembio.com Chembio is an Equal Opportunity Employer.