Inspector I

Description

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.

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