Plant Quality Inspector - Night Shift

JOB SUMMARY:

To provide customers a Quality product on a consistent basis. This is done by monitoring product quality routinely with various and physical inspections to assure it meets Quality Standards.

The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILIITIES:

QA Inspector I

1. Promote cGMP compliance in FDA/DEA regulated pharmaceutical manufacturing environment.
2. Perform inspections throughout the packaging packing process on in-process samples as well as finished products ready for release. Perform inspections of the packaging rooms and the packaging rooms and packaging lines for clearance purposes.
3. Record data and review documentation for cGMP compliance and accuracy. Develop a working knowledge of statistical based sampling plans.
4. Continuously develop a working knowledge of cGMPs, SOPs, WIs, and FDA requirements. Segregate, quarantine, document, and investigate non-conforming material incidents.
5. Initiate, document, and oversee Process Issues. Help to identify and present on-going initiative for continuous improvement to PAI’s quality process. Perform in-line inspection equipment challenges.
6. Calibrate and program in-line scales and document calibration. Help train new QA inspectors if needed.

QA Inspector II additional

1. Coordinate the inspection of the labeling components with other departments in order to support packaging operations.
2. Manage the labeling inventory and label storage area. Stage labeling items per the packaging schedule.
3. Daily warehouse management transactions for amount verifications, bin transfers, approvals, spot counters, and amendments. Return packaging components to inventory from reconciliation in Ross/Red Prairie.
4. Maintaining inventory using WMS and inventory cards.
5. Sample and inspect packaging components. Perform measurements w-calipers and scales.
6. Perform other related duties as required or assigned.

EDUCATION AND/OR EXPERIENCE:

1. High school diploma, or GED equivalent and/or on the job education in a specific sill area.
2. Plus 12-18 months related experience and/or training. Or equivalent combination of education and experience. Microsoft Software, and good math skills required.

KNOWLEDGE, SKILLS & ABILITIES:

• This position requires the individual be organized, detail-oriented, and self-motivated. Standard office equipment is used. Critical thinking and problems solving. Lead by example and communicate effectively, organize and prioritize workload.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g. computers, phones, etc.). Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 50 lbs. frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl along with working in confined spaces. Working knowledge of equipment in maintenance, manufacturing, and high-speed packaging areas. Gowning requirements while on the floor.

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled