Overview
Quality Assurance and Compliance Specialist Jobs in San Antonio, TX at Pet King Brands, Inc.
Position Summary
The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Manufacturing Technical Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.
The Manufacturing Technical Specialist role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!
The Role
Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations
Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
Develops, executes and oversees CAPAs
Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
Supports Tech transfer and process monitoring support as needed
Works with the team to monitor critical process parameters
Revision and management of manufacturing documents such as Batch Records and SOPs
Leads or supports Continuous Improvement projects
Conducts data gathering, trending, and data presentation as needed to support investigations
Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
The Candidate
Bachelor’s degree in a science or engineering field and 4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
3+ years of experience in process deviation investigations and remediation
Ability to perform interviews and familiarity with root cause analysis
Previous experience authoring and/or revising technical documents
Ability to support and/or lead system troubleshooting efforts
Job Types: Contract, Temporary
Pay: $18.00 – $21.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: On the road
Title: Quality Assurance and Compliance Specialist
Company: Pet King Brands, Inc.
Location: San Antonio, TX
