QA Release Tech II - 1st Shift
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
This position ensures that production and QC comply with cGMPs by reviewing GMP documentation including manufacturing and packaging batch records, component and raw material records, QC Lab documentation, and COAs and COCs. This position supports quality processes by initiating and executing HOLDs, managing hold status in SAP, initiating PRs in Trackwise, supporting investigations, dispositioning material in SAP, and working cross-functionally to identify, categorize and resolve Quality Events. This position supports internal and external customers by issuing batch records to production, creating COCs, identifying and resolving exceptions in records, performing online review on the manufacturing floor, overseeing and answering quality questions for contract manufacturing accounts, executing complex SAP transactions to manage batch status, authoring and revising procedures, initiating change controls, and escalating issues to management as appropriate to ensure quality processes and products. This position assists in training new employees, collects data for metrics, and serves as a resource for knowledge of processes, procedures and equipment.
KNOWLEDGE, EXPERIENCE AND EDUCATION
- Strong understanding of cGMPs, easily recognizes variances from cGMPs, and brings to resolution.
- Strong understanding of SOPs, and can explain requirements cross-functionally.
- Excellent oral and written communication skills, and interpersonal skills.
- Works independently and coordinates tasks to meet multiple deadlines.
- Broad understanding of manufacturing/packaging processes.
- General understanding of QC Laboratory.
- Intermediate computer skills, including Microsoft Word, Excel, SAP and Trackwise.
- High School diploma or GED required, with minimum of four years’ experience working in an FDA regulated industry or Bachelor's degree with minimum of two years' experience working in an FDA regulated industry. Degree preferred.
- Previous experience in a QA/QC role required. QC chemistry or chemistry lab experience strongly preferred.