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

NEPHRON SC, LLC•West Columbia, SC

10d•Onsite

About The Position

The Primary Packaging Supervisor is responsible for ensuring compliance with company policies, FDA, and cGMP regulations during the filling and packaging process. This role involves performing quality checks, ensuring the accuracy of batch records, and assisting with investigations and audits. The supervisor will also be involved in training, documentation review, and promoting teamwork within the QA department and with other departments. Key responsibilities include monitoring production, verifying materials, maintaining quality documentation, and releasing finished products.

Requirements

Four-function math skills
Good communication skills
Accurate and error-free work
Detail-oriented
Production assembly knowledge
Specific expertise, skills and knowledge within quality assurance gained through education and experience.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
The ability to manage a multitude of resources and to be accurate and current with data and information.
High School Diploma or GED required.

Nice To Haves

Bachelor’s degree preferred

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.
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.