SUMMARY: Responsibilities include adherence to and enforcement of GMP compliance, performing Quality inspections (components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes. The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the QA Inspector Level I position. Other duties may also be assigned. Responsible to ensure and enforce GMP compliance (including but not limited to: gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout GMP facility areas. Responsible to ensure the packaging record is being executed by all associates according to the process steps. Responsible for documentation, room identification, equipment and components as follows: Documentation: Ensure packaging record documentation is accurate (lot numbers, expiration dates, items number, equipment asset numbers, equipment calibration dates) and related data are consistent throughout the record; ensure AQL Report is accurate and complete, and error corrections are made according to GDP in a timely manner. Read and understand process steps within the packaging record to ensure compliance during the packaging process. Review packaging record and corresponding documentation for additional requests, memos, deviations, change controls, etc. Ensure room/equipment cleaning logs have been completed as applicable. Ensure room identification information matches packaging record. Review packaging record for accuracy, legibility, traceability and accountability at the end of each shift or lot, whichever is first. Equipment: Verify equipment asset numbers. Ensure equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the packaging record. Verify that calibrated equipment is appropriately labeled and within calibration date. Components: Verify each component’s attributes (at minimum: lot number, expiration date, description, item number and quantity) against Work Order, CoA/CoC, Component Receipt/Return Form and any other supporting documentation within the packaging record. Responsible for packaging record approval including AQL Sampling Plan calculation and/or verification and verification of label and pallet tag information prior to delivery to production room. Responsible for packaging record, component and equipment staging in production room. Responsible for verification of room cleans including proper completion of corresponding logbooks. Responsible for performing quality inspections as required per the packaging record and per AQL requirements, verification of challenges and collecting samples as required. Inspections may include visual, functional, destructive and count checks. Responsible for transaction and reconciliation verification. Responsible for periodic review of logbooks for completeness and accuracy. Responsible for training quality inspectors. Responsible for participating in continuous improvement projects. SUPERVISORY RESPONSIBILITIES: None QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: An Associate’s or Bachelor’s degree is preferred. A High School Diploma with (3) years related experience and/or training is required in lieu of a degree. Experience with inspection of pharmaceuticals or related industry is desired. General knowledge of FDA regulations related to cGMP is desired. General knowledge of quality control/assurance is desired. Good documentation and communication skills are required. Good organizational and planning skills are required. MATHEMATICAL SKILLS: The ability to apply moderately complex mathematical operations to assigned tasks is required; this includes an understanding of statistical sampling plans, and the ability to calculate time, percentages and decimals. Basic math skills (addition, subtraction, multiplication and division) are required. LANGUAGE SKILLS: The ability to effectively communicate written and verbally is required. Communication includes but is not limited to the following: Internal – Daily contact with Quality and Operations departments related to Quality and cGMP. External - Infrequent contact with customer representatives related to quality inspections. WRITTEN SKILLS: The ability to provide clear, concise and legible documentation within batch records, forms, and/or memos to file in conformance with basic Good Documentation Practices is required. REASONING ABILITY: The ability to make rational decisions pertaining to quality compliance is required. The ability to resolve problems effectively and efficiently is required. COMPUTER SKILLS: Working knowledge of basic Windows applications including Lotus Notes (e-mail) and Microsoft Office programs is required. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle, or write and to speak and hear. The employee frequently is required to stand, walk and reach with hands and arms. The employee must occasionally lift and/or move up to 30 pounds. The employee may be subject to mandatory overtime if scheduling requires. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to stand for long periods of time within a production room. The working environment is clean and not normally subject to hazardous environment or conditions.