Doc Control Associate
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POST DATE 8/5/2020
END DATE 8/8/2020
South San Francisco, CA
JOB DESCRIPTIONJOB DESCRIPTION
JOB #: 1078373
Day to Day Responsibilities:
Reporting directly to the Quality Manager, this Specialist works closely with the QC group to coordinate the timely release of materials and goods in support of manufacturing and business needs.
Support Manufacturing by monitoring processes and performing in-process QA checks to ensure product conformity to specifications.
Works with management to ensure current Good Manufacturing Practices (cGMP) are followed.
Release approve raw materials for production.
Perform final inspection, documentation review and Finished Goods release activities.
Assist with corrective action investigation and nonconforming product reports.
Assist with Quality System maintenance and continuous improvement activities.
Monitor QA metrics and frequently reporting to QA Management.
Assure that products, processes, facilities, and systems conform to quality standards 13485, cGMP and governmental regulations.
Author and review specifications and operating procedures with other departments.
Review Validation protocols and reports for equipment, computerized systems and manufacturing process for compliance to requirements.
Participate in/complete projects as assigned.
Support and coordinate calibration and preventative maintenance for equipment.
The successful candidate must be able to work overtime and be flexible in start times to support manufacturing and business needs. Good writer and verbal communication skills are required. Must be detail orientated.
BA/BS in Life Sciences or chemistry, (Open to entry level)
Preferred: up to 3 years related experience in a cGMP QA, QC or production environment.
Validation experience preferred.