NOTE: This document is a guideline and is not intended to be all inclusive of the job or work responsibilities. The employee understands that they are required to perform all work assigned by their supervisor provided it does not violate any laws or regulations, or expose the employee to any physical or health hazards.

Page 1 of 1 INCOMING QUALITY CONTROL SUPERVISOR-1.docx

INCOMING QUALITY CONTROL SUPERVISOR

Department: QUALITY ASSURANCE Classification: EXEMPT

Division: FERNDALE LABORATORIES, INC. Reports to: QA MANAGER

As Of Date: 5-14-2012 Other:

GUIDING PRINCIPLES: Expectations for All Employees Quality – Accountable for integrity and accuracy of work performed; cultivates continuous improvement. Professionalism – Contributes to a respectable environment. Teamwork – Effectively works with others; executes team decisions. People – Keeps others informed; strives for continual personal improvement. Entrepreneurialism – Takes calculated risks when appropriate; seeks opportunities; considers the customer’s perspective.

JOB SUMMARY Manages the activities of the Incoming Quality Control (IQC) department to ensure incoming raw materials, components and contract manufactured products meet their approved specifications or other regulatory requirements. Supervises IQC Operators.

ESSENTIAL FUNCTIONS • Ensures that IQC Operators conduct inspections according to approved procedures/specifications. • Audits inspection documentation for compliance and makes the final disposition for the materials. • Schedules and supervises IQC Operator activities. • Directs the training for IQC Operators • Supervises and coordinates Yearly Inspection of Retain Samples. • Tracks the status of incoming materials, ensures computer databases/worksheets are updated and keeps QA Manager and other appropriate

departments informed of inspection status. • Conducts quality investigations for non-conforming product and recommends corrective action / preventative action (CAPA) plan. • Reviews/revises department standard operating procedures (SOP) and master specifications for accuracy and conformance with

regulatory/vendor/compendia/other requirements.

ADDITIONAL RESPONSIBILITIES • May participate in FDA inspections and third-party audits as required. • Provides backup for data entry into the MFG-PRO inventory system. • All other duties as assigned.

KNOWLEDGE, SKILLS, & ABILITIES Must have previous supervisory experience. Requires exceptional knowledge of Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) regulations, International Organization for Standardization (ISO) regulations, U.S. Pharmacopoeia/National Formulary (USP/NF) and British Pharmacopoeia (BP) procedures. Must be familiar with American National Standard Institute (ANSI) Z1.4 or equivalent sampling plans. High degree of proficiency with verbal and written communication skills and effective multi-tasking skills. Must possess a proficient working knowledge of Microsoft Office suite, including knowledge of word processing, spreadsheet and database applications; PowerPoint experience is preferred. Must be self-motivated; organized; detail oriented/accurate; able to work independently to resolve problems. Proficiency in advanced mathematical techniques and experience with analytical balances and hand-held measuring devices such as calipers. To backup department, should be able to lift up to 50 pounds and be able to use a pallet jack, a drum dolly and a drum roller. Sampling activities may require standing for prolonged periods of time.

EDUCATION Requires a Bachelor of Science degree in a related scientific discipline and five (5)+ years experience in the pharmaceutical industry or a related FDA regulated industry, with at least two years in Quality Control/Assurance and one year in a supervisory capacity. Equal Opportunity Employer M/F/V. E-verify Participant.