Manufacturing Quality Inspector I

Position Summary

The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. He/she will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document a variety of visual, functional and dimensional testing in support of commodity/product release - particularly in the bag fabrication, overwrap and packaging areas of production.

3rd shift: Wednesday - Thursday (8:00pm - 6:30am); Friday - Saturday (6:00pm - 4:30am)

Essential Duties & Responsibilities

• Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues.
• Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met.
• Performs testing on commodities and final product and determines acceptance according to specifications.
• Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures.
• Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly.
• Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues.
• Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications.
• Uses good problem solving and interpersonal skills for effective communications. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings.
• Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE (personal protective equipment) is used, as required.
• Adheres to cGMP guidelines, SOP’s and plant policies/guidelines. Assists in monitoring area for cGMP compliance.
• Perform other related duties or special assignments as directed by supervisor.

Knowledge & Skills

• Must pass written and practical area requirements for area/certification.
• Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone.
• Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages. Must be able to input data into a computer, as required.
• Possesses good mechanical skills to handle lab equipment.
• Must be able to work independently and in a team environment. Must be dependable, competent and show good attendance.
• Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities.
• Adapts positively to a changing environment and/or situation.
• Must be able to maintain confidentiality with personal and business information.
• The incumbent will be expected to function independently with minimum supervision.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• High School Diploma required
• Minimum one years’ experience as a production operator or similar production or quality experience.

Work Environment

• The MQ Inspector position can directly impact the QA organization relative to business goals and documentation compliance. Non-compliance with government regulations (FDA, GMP, etc.), can negatively impact the organization with adverse audit observations.
• Work is performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time
• Must be able to occasionally move and lift objects of up to 25 lbs
• Typically requires travel less than 5% of the time