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.

Essential Duties: 

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties.

Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• 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.

Shop Floor QA Accountabilities:

• 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:

· 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.

Abilities:

· 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.

Education/Experience:

•  Bachelor’s degree preferred; High School Diploma or GED required.