Quantimetrix designs, develops, and manufactures clinical laboratory quality controls supporting the medical community. The Document Control Specialist role supports the Manufacturing Department ensuring compliance with cGMP standards via thorough document control. Responsibilities include authoring, reviewing, and revising SOPs, batch records, CAPAs, deviations, conducting departmental audits, assisting with laboratory experiments troubleshooting, and inventory management. The role also involves liaising between quality and manufacturing departments and supporting continuous improvement initiatives.
Candidates should have 2+ years experience in document control, quality assurance, or manufacturing in a cGMP-regulated environment, strong knowledge of cGMP, FDA regulations, quality management systems, and be proficient in ERP systems and Microsoft Office. The job requires excellent organizational and problem-solving skills and ability to handle multiple priorities.
The hourly wage is $30 to $35, with benefits including medical, dental, vision, life insurance, 401(k), FSA, PTO, education assistance, employee discounts, and assistance programs.
- Minimum 2 years experience in document control, quality assurance, or manufacturing in cGMP-regulated setting
- Strong knowledge of cGMP, FDA regulations, quality management systems
- Proficient in Microsoft Word, Excel, PowerPoint
- Experience with ERP systems such as SAP or IQMS preferred
- Excellent organizational, analytical, and problem-solving skills
- Ability to manage multiple priorities effectively
- Medical insurance
- Vision insurance
- Dental insurance
- Life insurance
- 401(k) matching
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Educational assistance program
- Employee discounts through PEO
- Employee Assistance Program
Location
California, US
Employment Type
Full-time
Experience Level
Entry Level
Remote work allowed
No
Posted
3 weeks ago