Job Description
Job Description
We are seeking a detail-oriented Quality Engineer I to join our team in Hollister, CA. In this role, you will be responsible for reviewing labels, batch records, and quality documentation to ensure compliance with GMP, ISO 13485, and company standards. The ideal candidate has a strong attention to detail, excellent documentation skills, and experience working in a manufacturing or regulated environment.
Location: Hollister, CA
Pay Rate: $37.50/hour
Schedule: Monday–Friday | AM Shift
Benefits: Medical, Dental, AD&D
Duties/Responsibilities
- Review batch records and work orders for accuracy and completeness.
- Review Work in Progress (WIP) receipts and QC reject records before product release.
- Verify labels and supporting documentation for product release.
- Maintain inventory records using an ERP system for raw materials and work-in-progress items.
- Ensure finished goods documentation complies with cGMP, ISO standards, and company procedures.
- Inspect packaging and labeling components to verify compliance with specifications.
- Manage the receipt, inspection, release, reconciliation, and control of labels and inserts.
- Receive and release raw materials and finished goods.
- Document and process rejected materials according to company procedures.
- Initiate non-conformance, deviation, and quality event reports.
- Support the Quality Assurance team with projects, audits, and administrative tasks.
- Scan and maintain quality control documentation.
- Assist production teams with troubleshooting and problem-solving.
- Train team members on configuration management procedures as needed.
Qualifications
- Bachelor's degree in Biological Sciences or a related scientific field, or an equivalent combination of education and experience.
- Experience in a GMP manufacturing, pharmaceutical, biotechnology, medical device, or similar regulated environment preferred.
- Familiarity with ISO 13485, 21 CFR Part 820, or other quality system regulations is a plus.
- Proficient in Microsoft Office (Word and Excel).
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
Physical Requirements
- Ability to stand and walk for extended periods.
- Frequently bend, lift, push, pull, and carry up to 45 lbs.
Benefits
- Medical Insurance
- Dental Insurance
- AD&D Insurance
Apply today and become part of a team committed to quality, innovation, and excellence!
Full Steam Staffing will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Full Steam Staffing is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting the California Department of Fair Employment and Housing’s Fair Chance Act webpage.