Document Control/Quality Assurance Specialist
- 4878 Ronson Ct, San Diego, CA 92111, USA
NanoComposix is a privately-held R&D and manufacturing company that develops innovative nanomaterials for research and commercial markets. We manufacture hundreds of different variants of metal and metal-oxide core/shell nanocomposites for a wide range of applications including biosensors, medical devices, clinical diagnostics, and optical effects. Our mission is to help our clients bring nano-enabled products to market. We’re passionate about what we do and are looking for smart, energetic, and self-motivated individuals who take pride in their work to join our fun and innovative team in this exciting industry.
Benefits include medical and dental insurance, paid vacation and personal days, retirement plan with company-match, and an annual bonus program with opportunity for stock ownership in this employee-owned business.
nanoComposix Inc., has an immediate need for a Document Control/Quality Assurance Specialist with experience in the medical device and/or pharmaceutical industries. This is a unique opportunity to help nanoComposix bring a wide variety of medical devices, topical therapeutics, and nanomedicines through clinical trials to commercialization.
The Document Control / Quality Assurance Specialist will be responsible for day-to-day administration and supporting various aspects of the Quality Management System, including: document control, receiving inspection, non-conforming materials program, calibration program, batch record/device history records reviews, training records, quality record management, etc. The Document Control / Quality Assurance Specialist coordinates and participates in Internal Audit activities, and Key Quality Initiatives.
Key Duties and Responsibilities include the following:
- Administrate the Document Control function and maintain all Quality Management System records.
- Support Manufacturing in generating and revising Bill of Materials, Raw Material Specifications, Labels, Finished Good Specifications, and Batch Records.
- Support R&D and Manufacturing Product Development in the Design Control process through Clinical Trials, and Commercialization. Transfer of methods to Manufacturing Batch Records.
- Coordinate Calibration & Preventive Maintenance Program activities and maintain related records.
- Maintain employee training records.
- Coordinate non-conforming material (NCR) & CAPA activities.
- Initiate Supplier Qualification process and follow-up with suppliers on product issues.
- Perform Batch Record/Device History Records reviews for product release.
- Coordinate and Participate in Internal Audit activities, External Audit activities, Key Quality Initiatives.
- Minimum – 2 year college degree
- Working knowledge of GDP; FDA 21 CFR, Part 820, Quality System Regulations; and ISO 13485.
- Working knowledge of FDA 21 CFR, Part 210 & 211; ISO 9001 a plus.
- Exceptional organizational skills
- Excellent written and verbal communication skills
- Capable of supporting cross-functional project goals with a Quality focus
- Ability to work effectively in a positive, fast-paced, start-up, team environment
- Scientific background in biology or chemistry
- Medical Device Experience – 3 years minimum in an application requiring chemical, biological, or nanomaterial reagent manufacturing. /Pharmaceutical Drug Experience - 3 years minimum in an application involving pharmaceutical drug development through manufacturing.
- SOP and Batch Record Experience – 3 years minimum drafting and releasing standard operating procedures and batch production records
- Document Control Experience – 3 years minimum
- Quality Assurance/Quality System Experience – 3 years minimum
Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter.
All your information will be kept confidential according to EEO guidelines.