Quality Operations Supervisor, Primary Packaging

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 50,000 - 70,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a Quality Assurance On-Line professional to oversee QA activities during filling and packaging, ensuring cGMP compliance and accuracy of batch records.

The role supports NCR investigations, deviations, audits, and SOP updates, while issuing and revising GMP documents. It also involves training, line inspections, material verification, and facilitating timely deviations notification.

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.
• Review QA procedures and component specifications for compliance and clarity.
• Ensures documentation systems reflect accurately both processing steps and accountability.
• Provides direction and assistance in documentation, team forming, and solution of problem solving and process improvements.
• Notifies QA Management immediately of deviations.
• 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

Communication skills

Detail-oriented

Production knowledge

Education

Bachelor’s Degree (preferred)

High School Diploma or GED (required)

Job description

Nephron Pharmaceuticals Corporation seeks a Quality Assurance On-Line professional to oversee QA activities during filling and packaging, ensuring cGMP compliance and accuracy of batch records.

The role supports NCR investigations, deviations, audits, and SOP updates, while issuing and revising GMP documents. It also involves training, line inspections, material verification, and facilitating timely deviations notification.