Job Description

Purpose & Scope:

Manage, plan and direct the Quality Control personnel to ensure lab testing provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations. Direct the work activities of the finished product / raw material and microbiology work groups to ensure that testing is executed in a timely and compliant manner. Coordinating laboratory activities to complement the duties and responsibilities of the Quality Control Manager.

Essential Job Responsibilities:

Perform testing of raw materials /or finished products and stability samples. Provide technical training and mentoring to other members of the group. Ensure GMP compliance of all internal testing. Assist management in department planning. Perform the weekly testing schedule and assign the tests according to manufacturing and /or stability requirements or product deadlines. Review and/or verify the laboratory data/ results for accuracy and completeness as required per applicable procedures and/or test methods. Review chemical and physical testing data/ reports ensuring that materials/ products are tested in compliance with company specifications, policies and government regulations. Perform the duty as investigator on laboratory investigations. Attend daily and weekly meetings pertaining to the release of products. Participate in OPEX Initiatives and activities. Work cooperatively in a team environment supporting senior laboratory and management staff. Enforce safety procedures and consult with other supervisors about these issues. Responsible for exhibiting professional behavior that reflects positively on the company and is consistent with the company's policies and practices. Perform other duties as directed.

Quantitative Dimensions:

Work cross-functionally with local teams, directly impacting APT's commercial products

Organizational Context:

Reports to the Manager of Quality Control Supervision of direct reports including Chemists and Laboratory Technicians

Qualifications:

Required

Education: BS in Chemistry, Biology, Microbiology or another related field with 5 years of experience preferred Experience: 5yrs in pharmaceutical laboratory as an analyst. Thorough knowledge of pharmaceutical cGMP and FDA and proficiency in their appropriate application Excellent verbal and written communications with demonstrated operation in a team environment Extensive and current understanding of common analytical tools and instrumentation including volumetric glassware, balances, HPLC, GC, FT-IR, UV-Vis, and the ability to identify problems that may occur and evaluate data to determine solution. Microsoft Excel and Word experience required A minimum lifting requirement of 10 lb. Must be able to read, write and understand the English language (statement common to all Job description). * Requires the ability to climb flights of stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes