Quality Assurance Supervisor - (Nights - 12 hr. Shift)

Impax Laboratories, Inc. is a technology based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.

Job Summary: Plans, coordinates, and oversees quality assurance program designed to ensure quality production of products consistent with established standards by performing the following duties personally or through subordinate employees.

 

Essential Duties and Responsibilities:

·  Formulates and maintains quality assurance objectives complementary to corporate policies and goals.

·  Supports production floor by prioritizing, coordinating, and assigning QA tasks to shift personnel.

·  Performs quality assurance activities (in-process testing, AQL Attribute inspection, approving processing rooms, GMP inspection, raw material/component sampling, file maintenance).

·  Reviews/audits all data obtained during quality assurance activities to ensure consistency with company policies and procedures (completed batch records, in-process test results, AQL attribute inspection, etc.).

·  Writes and reviews Investigation Reports. 

·  Responds to GMP-related questions on production floor and advises proper direction.

·  Trains new employees on quality assurance procedures.

·  Writes, reviews, approves company GMP-related SOPs.

·  Investigates customer complaints regarding quality.

·  Develops new approaches to solve problems identified during quality assurance activities.

·  Performs supervisory/management responsibilities (hiring, performance evaluations, coaching, etc.).

·  Maintains a working knowledge of government and industry quality assurance codes and standards.

·  Performs special projects assigned by management.

·  Other duties as assigned.

 

Supervisory Responsibilities include oversight of QA Associates and QA Technicians.

 

Requiremnets:

·  College degree in science or equivalent experience. 

·  3-5 years experience (pharmaceutical industry preferred). 

·  At least 1 year supervisory experience. 

·  Experience in production floor work in related industry. 

·  Experience in auditing and FDA inspections desirable. 

·  Knowledge/experience in DEA procedures for controlled substances desirable. 

·  Good writing skills and ability to write reports and memos. 

·  Good verbal communications. 

·  Must have the ability to relate and work well with people. 

·  Able to handle multiple tasks and make quick sound decisions. 

·  Working knowledge of computers (Word, Excel, Access, etc.).