Quality Assurance Assistant (Temp Role)

Job Description

Job Description

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare specializes in high quality IHC, ISH, and FISH slide staining through its brand-new automated instrument, NeoPATH Pro™, and offers best-in-class simultaneous Multiplex IHC solutions.

The company's customers include clinical histology laboratories, pharmaceutical companies, CROs, biotechnology companies as well as academic, government, military, and 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 with a global distribution network.

Summary/Objective

Responsible for assisting with Quality Assurance and Quality Control activities related to product release and compliance.

Essential Functions

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

• Scans documents/records including but not limited to product manufacturing, quality control testing, and quality management system related processes and files them according to Biocare Medical's record keeping process.
• Performs line clearance and approval tasks by thoroughly reviewing manufacturing and quality control documentation and calculations to ensure accuracy and compliance with departmental processes.
• Creates and reviews Certificates of Analysis and Conformity.
• Utilizes the electronic system tools to ensure compliance and support good documentation practices.
• Other duties as assigned by Management.

Competencies

• High School Diploma or GED required with a minimum of 1 year of experience in a GMP regulated facility.
• High-level reading comprehension.
• Ability to write clear, understandable documentation with effective presentation of information.
• Demonstrates independent judgment within broadly defined policies and practices in resolving problems and making recommendations.
• Basic computer literacy.
• Working knowledge of FDA/GMP/ISO standards.
• Ability to work in a high-pressure, deadline-oriented environment.
• Understanding of basic math principles (arithmetic, significant figures, etc).
• Experience in a GMP-regulated facility.
• Working knowledge of Good Documentation Practices (GDP).
• Experience in a wet lab environment desired but not required.

Compensation Range

• $18 - $22 Hourly

Expected Hours of Work

• 7:00 a.m. to 4:00 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 with a match - 401(k)
• PTO
• Paid Holidays
• EAP

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.