The QC Group Leader for any Quality Control lab is responsible for all aspects of the quality control laboratory operation including directly supervising and training all Quality Control staff. Responsibilities include maintaining and fostering a cGMP environment according to guidelines established by OraSure Technologies and regulatory agencies for all staff engaged in procedures that include evaluation of raw materials, in-process components, finished products, product development studies, stability testing, investigational testing, equipment quality control, and equipment maintenance. This position is on a 2nd shift 2:30-11pm
Effectively supervises all Quality Control Personnel for the specified laboratory or laboratories.
Performs and documents training of personnel.
Performs scheduling of staff.
Assists in completing staff performance reviews.
Oversees routine operation of the Quality Control Departments.
Independently performs and ensures completion of testing at all levels of production including raw materials, in-process components, finished products and stability testing.
Independently performs and ensures completion of all visual finished product inspections.
Independently performs and ensures completion of customer complaint investigations including required testing, evaluations and batch history reviews.
Perform failure investigations at the direction of the Manager, or Supervisor of Quality Control for that area.
Recommend acceptance or rejection of raw material, component, finished product and other materials evaluated based on established specifications.
Ensures departmental regulatory compliance.
Provides staff development for QC staff to ensure appropriate guidance, training, supervision and support needed is provided to follow organizational policies, procedures and objectives established for Quality Control.
Document all paperwork according to procedures and protocols. Completes appropriate computer entries accurately.
Maintains neat and legible manual forms.
Maintains a clean, organized work area and keeps supplies stocked at the bench.
Writes and/or revises new and existing work instructions.
Conduct and report on the product stability testing program designed to support product stability claims; recommend storage and shelf life claims according to data.
Develop and maintain systems to track trends in product and component quality.
Identify and report on positive and negative product quality trends through trend analysis.
Develop improved quality test methods, equipment and standards intended to increase product quality or productivity or reduce operating costs.
Actively participates in writing and performing validation protocols.
Actively participates in writing PD Study protocol and writes studies required for investigative testing.
Ensures an adequate inventory and supply items are maintained.
Notifies Manager or Supervisor, Quality Control/designee of equipment and/or procedural problems.
Responds to all problems, complaints and special requests in a timely manner.
Performs self assessments for process improvement.
Performs other job duties and special assignments as put forth by the Manager or Supervisor, Quality Control.
4 year degree in Chemistry, Biology, Medical Technology, Related Science
CQT (Certified Quality Technician) certification preferred
CQE (Certified Quality Engineer) certification preferred
Previous supervisory experience preferred
5 years previous laboratory experience
Analytical experience in analytical test methods, EIA and GC/MS preferred.
Computer Proficiency (Excel, Word, Access, Power Point, Statistical Software, Preferably Minitab)
OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.