Assistant Quality Unit Manager

Keystone Industries • Gibbstown, NJ

5d • Onsite

About The Position

Coordinate activities required to direct and control manufacturing quality. Support or oversee the Quality Unit (QU) activities as required by FDA 21CFR Parts 210/211 and 820, including but not limited to the essential functions, listed below. The ideal candidate will have a minimum of 5 years’ directly related experience, with demonstrated knowledge of FDA CFR 210 & 211 cGMP Pharma requirements, and FDA CFR 820 / ISO 13485 cGMP Medical Device requirements.

Requirements

• Minimum 5 years’ directly related experience.
• Experience working with chemistry, biology, math, or another related technical field and/or working within the pharmaceutical industry.
• Strong knowledge or background in a manufacturing Quality Control/Assurance environment.
• Demonstrated knowledge of FDA CFR 210 & 211, cGMP Pharma requirements.
• Demonstrated knowledge of FDA CFR 820 / ISO 13485 cGMP Medical Device requirements.
• Exceptional computer skills, including Microsoft Office Suite; Ability to learn and leverage new systems.
• Proven ability to perform under deadlines, to adjust plans to meet changing needs and requirements.
• Excellent oral, written, listening, and presentation skills and ability to clearly articulate complex information to others.
• Strong attention to detail, demonstrated integrity and professionalism.
• Must be an effective team player.
• Self-starter, strong initiative, dependable and capable of following through with minimal supervision.
• Ability to effectively train, engage, and motivate.

Nice To Haves

• Experience in leadership or supervisory role.
• Experience in a manufacturing environment.
• ERP/MRP software experience.
• QMS experience.

Responsibilities

• Provide, and oversee, inspection activity for cosmetic finished goods, as well as drug and medical device products throughout their product cycle.
• Perform appropriate customer complaint and product nonconformance follow-up and close-out activities including Product Conformance and Out-of-Specification (OOS) Investigations, Corrective / Preventive Action Requests, Nonconformance Product Reports, etc.
• Under QU Management guidance, continuously review department processes, procedures, and capabilities to sustain the most cost-effective and efficient methods for meeting quality requirements; suggest recommendations for improvement as appropriate.
• Assist with the authoring and revision of procedures, batch cards and specifications impacting the identity, strength, quality, and purity of drug and medical device products.
• Ensure procedures are appropriate, implemented, trained to, and consistently followed.
• Ensure any deviations from established procedures are recorded and justified.
• Participate in regulatory agency & other third-party audits/inspections & associated Nonconformance closures.
• Conduct or oversee validation activities, such as sample collection and shipment.
• Responsible for reviewing contract QC, cleaning validation & stability lab data, documentation related to test method validation, requesting rework, OOS Investigation, and resolving lab related issues.
• Oversee label control system/functions.
• Coordinate with external and internal laboratories for product testing.
• Assist with the approval of testing invoices.
• Participate in projects related to quality system improvement.
• Work independently or under minimal supervision of QU Manager to provide periodic updates, and furnish reports and/or presentations, and ensure adherence to deadlines.
• Initiate the ordering of chemicals, consumables, and equipment as necessary.
• Verify that equipment is maintained and calibrated appropriately.
• Participate in graphic art QC approvals.
• Assist in conducting vendor assessments.
• Serve as a senior resource for the Quality Unit team, offering guidance, training, and mentorship to support team development and collaboration.
• Assign supplemental projects to team members and help monitor progress.
• Contribute input to performance feedback and development discussions for team members.
• Ability to provide coverage for Quality Unit functions in the absence of Quality Unit staff, including completion of on‑floor inspections and related quality activities.
• Perform additional duties/tasks as needed or requested by management.
• Comply with all safety regulations; maintains a safe work environment at all times.
• Adhere to always wearing the proper PPE/Safety equipment.
• Understand and comply with all written safety, health, and environmental procedures.
• Attend all required scheduled Health, Safety and Environmental training sessions.
• Participate in required Health, Safety and Environmental initiatives and programs.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.

Benefits

• Weekly Pay
• Comprehensive Health Coverage - Medical, Dental & Vision Plans
• Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options
• Company-Paid Life Insurance + Additional Voluntary Options
• 401(k) Retirement Plan with 3% Employer Contribution (after 1 year)
• Fitness Benefits - Onsite Gym (Headquarters) or Membership Reimbursement (other sites)
• Paid Time Off & Holidays to support work-life balance
• Employee Assistance Program (EAP) for confidential support
• Financial Wellness Resources
• Employee Discounts & Perks (Eagles games, concert tickets, etc.)
• Company Social Events & Team Activities
• Career Development Opportunities & Internal Growth

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level