Quality Control Manager

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods

SUMMARY:

The Quality Control (QC) Manager is responsible for leading and managing Quality Control laboratory operations to ensure the timely testing, release, and compliance of raw materials, in-process materials, bulk, stability, and finished products. This role ensures adherence to current Good Manufacturing Practices (cGMP), FDA regulations, and company quality standards while providing strong leadership, technical expertise, and continuous improvement within the QC function.

Work schedule: Monday- Friday 8am-5pm

JOB QUALIFICATIONS:

• Bachelor’s or Master’s Degree in Chemistry, Biology, or a related scientific discipline
• Minimum of 7 years of experience in a Quality Control laboratory environment within a regulated industry (pharmaceutical, biotech, or related)
• Strong working knowledge of cGMPs, FDA regulations, and FDA guidance documents
• Demonstrated leadership and people management experience
• Proven ability to plan, organize, and manage multiple priorities and projects simultaneously
• Strong attention to detail with consistent focus on data integrity and compliance
• Ability to work effectively in a fast-paced, matrixed environment, both independently and as part of a team
• Excellent verbal, written, and interpersonal communication skills
• Computer proficiency, including experience with laboratory systems and standard office software

POSITION RESPONSIBILITIES:

• Directly supervise and provide leadership to QC laboratory technical and support staff
• Manage the development, implementation, and continuous improvement of QC goals, objectives, procedures, and systems in alignment with company policies and cGMP requirements
• Establish, review, and maintain analytical procedures, methods, and testing guidelines
• Establish and maintain testing schedule to assure adherence to Quality On Time Release (OTR), including Raw Materials, In-Process, Finished Product and Stability
• Recruit, train, coach, and develop QC staff; assign work, monitor performance, and conduct performance evaluations
• Perform or oversee analytical testing, data review, and approval activities as needed
• Oversee raw material testing, in-process testing, bulk testing, stability testing, and finished product testing
• Supervise and participate in stability programs, method transfers, and analytical method validations
• Ensure the development, review, approval, and maintenance of Certificates of Analysis for bulk and finished products
• Oversee the laboratory equipment qualification, calibration, and maintenance programs
• Lead laboratory investigations, deviations, OOS/OOT investigations, and recommend corrective and preventive actions (CAPAs)
• Develop, review, and maintain Quality Control Standard Operating Procedures (SOPs)
• Support internal and external audits, inspections, and regulatory agency interactions as required
• Partner cross-functionally with Quality Assurance, Manufacturing, R&D, and other departments to support product quality and continuous improvement initiatives
• Perform additional duties as assigned by the Head of Quality
• Ensure QC Laboratory compliance with 21 CFR 210 & 211 and Part 11
• Lead as an QC SME for Internal, Client and Regulatory Audits as needed

PHYISICAL REQUIREMENTS:

• Adhere to all safety policies, including the use of personal protective equipment when required
• Light physical activity performing non-strenuous administrative and laboratory duties
• Sitting for greater than 75% of the workday; standing and walking up to 25%
• Manual dexterity sufficient for handling laboratory equipment, samples, and computer work
• Use of hands and fingers for typing and laboratory tasks up to 75% of the time
• Occasional reaching, bending, kneeling, crouching, or climbing less than 25% of the time
• Ability to lift up to 50 pounds less than 25% of the time
  
  

BENEFITS:
PLD is a proud employer offering many corporate benefits, including:

⦁ Medical and Dental Benefits

⦁ Vision

⦁ 401K with employer match

⦁ Group Life Insurance

⦁ Flex Spending Accounts

⦁ Paid Time Off and Paid Holidays

⦁ Tuition Assistance

⦁ Corporate Discount Program

⦁ Opportunities to Flourish Within the Company

PL Developments 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, disability, or veteran status.

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