QA Packaging Supervisor - cGMP & Compliance Champion

Nephron Pharmaceuticals Corporation; Columbia (SC); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a diligent QA professional to ensure compliance on shift, perform weight checks and quality attribute inspection, and verify batch records. You will support NCR investigations, document issuance, GMP training, and line clearances while maintaining clean, compliant production areas.

The role requires collaboration with QA and other departments, adherence to cGMP and FDA guidelines, and strong attention to detail in all inspections and releases.

Qualifications

• Four-function math skills, good communication skills, accurate and error free work and detail oriented.
• Production assembly knowledge.
• Specific expertise, skills and knowledge within quality assurance gained through education and experience.

Responsibilities

• Manages the quality assurance activities during the manufacturing process concerning cGMP.
• Assists with NCR investigations and deviations as well as audits and reviews.
• Reviews SOPs and recommends updates for GMP documents.
• Assists with the issuance of documents during shift work.
• Assists with creating and /or the revising GMP documents.
• Coordinate and conduct GMP training and retraining of QA On-Line personnel with Trainer to ensure compliance of procedures.
• Monitors and perform start up, in-process and finished product inspections including weighing.
• Maintain quality documentation.
• Promotes teamwork both within the QA Team and other departments.
• Keep line and work station clean and orderly.
• Verify incoming packaging materials, raw materials, in process and finished products.
• Ensure that there is no product or line contamination.
• Perform line clearances.
• Inspect and 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 all completed production batch record documentation to ensure completion and compliance.
• Investigates out of range percentages.
• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
• Assist with development of solutions for chronic problems within quality assurance
• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
• Assist in other activities (as needed) for Quality Assurance management.

Skills

Math skills

Quality assurance

Communication

Detail oriented

Education

Bachelor’s degree preferred

High School Diploma or GED required

Job description

Nephron Pharmaceuticals Corporation seeks a diligent QA professional to ensure compliance on shift, perform weight checks and quality attribute inspection, and verify batch records. You will support NCR investigations, document issuance, GMP training, and line clearances while maintaining clean, compliant production areas.

The role requires collaboration with QA and other departments, adherence to cGMP and FDA guidelines, and strong attention to detail in all inspections and releases.