Allergan Manager, Quality Assurance in Cincinnati, Ohio

Manager, Quality Assurance

Cincinnati, Ohio, United States at https://agn.referrals.selectminds.com/jobs/5164/other-jobs-matching/location-only

Apr 24, 2018Post Date

179349Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

  1. POSITION SUMMARY:

The Manager QA is responsible for day-to-day operation of QA Inspections and Product Release. He/She manages personnel and associated activities ensuring compliance with established regulations, product submission, and standard operating procedures governing the Warehouse, Manufacturing, and Packaging. Manager QA also manages hiring, developing, evaluating, and counseling of his/her staff. He/She provides feedback on a regular basis and prepares formal performance evaluations.

II. PRIMARY JOB RESPONSIBILITIES:

  1. Manage the day-to-day activities of the QA Inspections and Product Release Department. Establish work schedules and prioritize activities to meet Allergan Cincinnati requirements. Ensure adherence to work schedules and project timelines.

  2. Manage the following Quality Systems. Manage and effectively communicate the potential impact of QA activities in other departments.

  • Non-Conformance (Deviation) and Complaint Investigations

  • Incoming sampling (RM And Component)

  • OOS Investigations

  • Environmental Monitoring

  • Calibration/PM/BAS Oversight

  • Product Quarantine and Release for Production

  • QM Master data

  • Master Batch Record and other Controlled Document Review/Approval

  1. Direct investigations into all non-conformances, complaints, and OOSs as they pertain to the cGMP operations at the Cincinnati facilities. Ensure that investigations are completed in a timely manner. Ensure effective Corrective/Preventive Actions are assigned. Review and approve/reject investigations, confirming conclusions are accurate, reflect the supporting data, and products are appropriately dispositioned/controlled.

  2. Ensure GMP activities across the sites are compliant, sustainable, and are being followed.

  3. Provide direction to QA, production, warehouse, and laboratory employees regarding interpretation of SOPs, regulatory guidance documents, and methods where instructions may not be clear.

  4. Determine disposition of potentially non-conforming product and/or raw materials in the Warehouse, Manufacturing, and Packaging. Resolve supplier related quality issues.

  5. Coordinate communication with internal and external QA departments (Allergan and Suppliers/Partners) to ensure control and compliance of Allergan products.

III. ADDITIONAL JOB RESPONSIBILITIES:

  1. Provide assistance to Sr. Manager QA and Site Quality Head, and perform other duties as assigned.

  2. Lead initiatives to improve effectiveness, productivity, quality, and compliance across sites.

  3. Provide input on yearly departmental budget.

Requirements

Experience: A minimum of –2-3 years of supervisory/management experience in the pharmaceutical or regulated healthcare industry is strongly preferred.

Licensure/Credentials:

No special requirements.

Knowledge, Skills, and Abilities : Incumbents must be detail-oriented, have the ability to prioritize multiple tasks, and demonstrate strong organizational and communication skills. The position requires thorough understanding of pharmaceutical cGMP compliance documentation requirements. The position requires proficiency in the use of Microsoft Word, Excel, Access, Power-Point, Outlook and Explorer. Knowledge of electronic systems for batch records and regulatory submissions is desirable, such as SAP and TrackWise

Education

Education : A bachelor’s degree in biology, chemistry, engineering, pharmacy, or similar scientific discipline.

#LI-JE4

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.