Job Description

Overview

Lead and coordinate activities of QA Inspectors I and II. Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards.

Responsibilities

• Under the direction of the supervisor and/or manager, schedule duties and work assignments of QA Inspectors I & II.
• Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel.
• Approve components for in-process operations.
• Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations.
• Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance.
• Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments.
• Review records for cGMP compliance for accuracy and thoroughness.
• Investigate failures and deviations in manufacturing operations and initiate corrective action.
• Inform management of problems, failures and deviations from established internal and regulatory standards.
• Help train/mentor QA Inspectors I & II.
• Apply disposition stickers to components and in-process materials.
• Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage.
• Perform swab and Rodac Plate sampling as required.
• Perform transactions in JD Edwards when required.
• Assist in Validation Projects.
• Provide assistance to supervisor and/or manager in performing/documenting SICOD investigations, as required.
• Assist supervisor and/or manager in obtaining information for status/monthly reports to management.

Qualifications

Competencies:

Education / Experience:

Minimum High School diploma or equivalent. Minimum four years of professional experience in similar position; demonstrated ability to perform required duties. Knowledge of internal SOPs, cGMPs, FDA/DEA regulations. PC literate with basic knowledge of office application software. Basic math skills required (i.e., calculating %, addition, subtraction, division). Ability to read, write, communicate and follow/give instructions (verbal and written) in English is required. Familiarity with sampling methodologies (i.e. AQL, ANSI-stds) required.

Possess and/or obtainment of a current ASQ Certification.

Judgment / Decision Making:

Duties performed within a framework of departmental or functional protocol requiring a moderate degree of original thinking and supervision. Makes routine and informed recommendations.

Work Environment:

Majority of time spent at Manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury.

ability to work second and third shift if required. Ability to work Saturday and/or Sunday if required.

Physical Demands:

Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer. May handle or work with laminates and units containing a Class II Controlled Substance.