Quality Assurance Manager

We have an immediate opening for Manager, Quality Assurance Pharmaceutical Environment prefer. Please submit salary requirement with resume. Scope of the job:  Shared Management of Quality Assurance, Compliance and Validation in conjunction with 21 CFR Parts 210 & 211, Part 11, GMP and Good Manufacturing Practices.  Assures that all operational and quality systems are appropriately documented and function in compliance with all regulatory requirements and internal SOP’s.  Manages Daily Departmental Operations for all Quality Assurance Areas and Validation.  Oversees the preparation and approval of Quality & Validation Master Plans.  Will develop Quality System improvements; interacting with directors, managers and supervisors; applying continuous improvement quality principles to all operating areas. Responsibilities: Management Responsibilities Include: QA Compliance, Final Document Review and Sample Coordination. The position includes these responsibilities;  Managing all aspects of Quality Assurance  Contract Testing of Packaging Components  Change Control Management  Release of Finished Product Inventory  Rejections  Internal and External Audits  Regulatory Agency Communication  Review and Approval of SOP’s, Customer Complaints, Investigations, Deviations, CAPA Planning & Execution, Master Packaging Orders, Annual Product Reviews.

 Regulatory Licensing, ARCOS and DEA Quota Applications.  ERP System Compliance Support Manages the following direct reports:  QA Compliance Staff  Final Document Review Staff  QA Sample Coordinator Qualifications:  Bachelor’s Degree in a related field.  Minimum of 5 years’ experience in Pharmaceutical Quality Assurance and Compliance. Experienced in GMP and application of 21CFR Parts 210 & 211 as well as Part 11 compliance.  Ability to train and manage staff.  Must possess ability to communicate verbally and in writing at all management levels.  Familiar with a variety of the field's requirements, practices, and procedures.  Relies on extensive experience and judgment to plan and accomplish goals.  Performs a variety of tasks.  Leads and directs the work of others at a management level.  A wide degree of creativity and latitude is expected.  Must have a good command of the English Language, both written and verbal. Physical Demands:  Must be able to sit, stand and walk for long periods of time.  Must be able to spend long periods working at a computer and reading.  Must be able to lift 30 pounds

Job Type: Full-time

Salary: $90,000.00 - $100,000.00 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Wayne, NJ 07470: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• ISO 9001: 1 year (Preferred)
• Quality Assurance Managers: 1 year (Preferred)

Work Location: One location