Quality Assurance Specialist

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.

The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.

Summary/Objective

Responsible for providing guidance on Biocare’s quality management system (QMS). Support audits and inspections as necessary. Ensure compliance with company quality programs, policies, processes, procedures, and FDA QSR, ISO, and other global regulations. Collaborate with various departments to address quality concerns and improve processes.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ensure adequate documentation and compliance with procedures and regulation requirements
• Acts as Document Control and QMS subject matter expert.
• Maintains quality document records according to policies.
• Writes procedures, protocols, plans, and reports as well as maintaining and updating the documents.
• Supports internal/external audits to ensure compliance with subject regulations.
• Prepares and/or delivers inter-/intra-training presentations related to quality management.
• Strengthens quality awareness and actively works with all departments to provide solutions to improve processes efficiency and operational excellence.
• Identifies quality improvement opportunities, compliance concerns, identify, prevent, and resolve deviations.
• Support and/or perform customer complaints investigations, reporting, and analysis. 
• Supports QMS programs (e.g., change control, planned deviation, CAPA) to ensure compliance, effectiveness and efficiency.
• Reviews and approves batch records, forms and specification sheets and other documentation for accuracy and completeness, and recommends changes as needed.
• Processes intra-/inter-departmental quality assurance requests for document control and QMS related documentation via FreshWorks, PolicyTech, etc.
• Maintains and tracks QMS programs as necessary, including facilitating the progress of deliverables.
• Other duties as assigned by Management.

Competencies

• BS/BA degree or equivalent experience. 
• Preferred three (3) to five plus (5+) years’ experience in QA disciplines in medical device or pharmaceutical industry.
• Experience with quality management systems and audit support.
• Certification or training in QMS, ISO standards, regulatory compliance, and GDP preferred.
• Working knowledge of quality systems, QA audit.
• Attention to detail and good organizational skills.
• High level of reading comprehension.
• Able to write clear & understandable documentation with effective presentation of information.
• Demonstrates independent judgment within broadly defined policies and ability to lead projects.
• Advanced computer skills required.
• Experience with FDA QSR, ISO 13485, and ISO 14971 requirements.

Compensation Range

• $70,500 to $80,500 Annually

Expected Hours of Work

• 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Full-Time Positions Offer

• Company Sponsored Health Insurance - medical, dental, vision,
• Company Sponsored Life Insurance
• Voluntary Benefits
• Retirement plan - 401(k)
• PTO
• Paid Holidays

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

All inquiries strictly confidential.