QUALITY ASSURANCE MANAGER Job Opening in Wayne, NJ

Full Job Description

Reports To: President

Scope:

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 SOPs. Manages Daily Departmental Operations for all Quality Assurance Compliance and Batch Record Review. Will develop Quality System improvements; interact with directors, managers, and supervisors; applying continuous improvement quality principles to all operating areas.

Responsibilities:

• Develops, implements, and manages the Quality Assurance Systems Personnel and procedures governing the handling of products and components for packaging 

Manages the following direct reports:

· Validation

· QA Compliance Staff

• Provides leadership, guidance, and direction to the Quality Staff in support of achieving individual goals, goals of the department, and goals of the Reed-Lane organization.
• Provides representation and communication during audits with Customer Quality Units and Regulatory Agencies.
• Review and approval of SOPs, investigations, deviations, complaints, and validation protocols and reports.
• Assures that all deviations, non-conformances, and customer complaints are appropriately investigated and assures that necessary corrective and preventive actions are documented, implemented, and deemed effective.
• Review and approval of Reed-Lane and Customer Annual Product Reviews.
• Supports development projects by performing due diligence/evaluation audits of potential partners for Reed-Lane, including performing GMP audits
• Works in partnership with customer’s Quality Operations Managers.
• Ensures that the necessary documents are available and provided for regulatory applications.
• ERP System Compliance Support.
• Negotiate and implement Quality Agreements.
• Oversees Internal and External Audits.
• Responsible for requisition approvals in the ERP system.
• Manage all required State and Federal Registrations.
• Manage List 1 Chemical Quota Applications and Quota Inventories.
• Manages DEA requirements and prepares and submits quarterly ARCOS reporting.

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 the 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.

Training:

New hires or transfers into this position shall be given a three-month trial orientation period in order to become proficient. Proficiency shall be evaluated by the area manager or trainer and become part of the employee’s training record.

Job Type: Full-time

Pay: $100,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay