QO Primary Packaging Supervisor (Shift 3 6pm-6:30am)

Job Purpose

Be accountable and responsible for compliance on shift. Performs weight check and quality attributes inspection of the product through the filling and/or packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ensures the accuracy and completeness of batch records. Assists with and performs additional work duties or responsibilities as evident or required.

Responsibilities

• Manage quality assurance activities during the manufacturing process concerning cGMP.
• Assist with NCR investigations, deviations, audits, and reviews.
• Review SOPs and recommend updates for GMP documents.
• Assist with the issuance, creation, and revision of GMP documents during shift work.
• Coordinate and conduct GMP training and retraining of QA on‑line personnel with trainers to ensure procedural compliance.
• Monitor and perform start‑up, in‑process, and finished‑product inspections, including weighing.
• Maintain quality documentation and promote teamwork within the QA team and other departments.
• Keep line and work stations clean and orderly.
• Verify incoming packaging materials, raw materials, in‑process, and finished products; ensure no product or line contamination.
• Perform line clearances and inspect/release machines and processing rooms for production.
• Support validation and manufacturing studies, including special sampling and testing.
• Organize workload during lot and batch changeovers for efficient execution.
• Review and approve production batch records; release finished product for packaging.
• Review completed production batch record documentation to ensure completion and compliance.
• Investigate out‑of‑range percentages and review QA procedures and component specifications for compliance and clarity.
• Ensure documentation systems accurately reflect processing steps and accountability.
• Provide direction and assistance in documentation, team formation, problem solving, and process improvements.
• Notify QA management immediately of deviations.
• Assist with monitoring all production areas and personnel for adherence to cGMP, SOPs, and safety regulations.
• Develop solutions for chronic quality‑assurance problems.
• Communicate quality‑related observations, issues, discrepancies, and policy violations to Quality Management.
• Stay abreast of current FDA requirements and ensure compliance through familiarity with SOPs and routine observance.
• Assist in other activities as needed for Quality Assurance management.

Requirements

• Skills: Four‑function math skills, good communication skills, accurate and error‑free work, detail‑oriented, production assembly knowledge, specific expertise in quality assurance gained through education and experience.
• Abilities: Ability and willingness to change direction and focus to meet shifting organizational and business demands; ability to manage oneself, demonstrate integrity, be productive under pressure, and achieve development goals; ability to take strategic objectives, accept accountability, motivate and influence others, think globally, and leverage diversity; ability to manage multiple resources and maintain accurate, current data and information.
• Education/Experience: Bachelor’s degree preferred; High School Diploma or GED required.