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Product Documentation Associate

Salary undisclosed

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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 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

Assists the activities associated with IVD reagent development under Design Controls. Supports documentation of new product development and sustainability of existing products to ensure accurate and complete Design records. Contributes to the overall Quality Systems compliance of the Reagent R&D group.

Essential Functions

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

  • Product Development/Design Control
    • Facilitates product development projects.
    • Drafts Design documents for review by Director, New Product Development.
  • Document Review
    • Assists technical document review including, individual test records, data sheet revisions, product labeling, SOPs and other design output documentation.
    • Assists in editing product data sheets and revising departmental procedures.
    • Revises documents related to product implementations and discontinuations.
  • Laboratory Management
    • Participates in selected routine laboratory activities, including drafting purchase requisition, ordering of selected laboratory supplies.
  • Cross-Functional Responsibilities
    • Assists with monitoring the progress of all new reagent products through the Product Development Life Cycle (PDLC) process, internally in Reagent R&D, as well as externally through MFG, QC, QA, and Marketing to identify potential obstacles.
    • Complies with GMP requirements and assists the New Product Development Team in development of new products, including organizing test results, drafting selected documentation, proofreading of documentation, slides scanning and drafting grading forms etc.
    • Assists in oversight of antibody raw material inventory in R&D
  • Other duties as assigned by Management.

Competencies

  • Bachelor's Degree in Biology or a related field with 0 - 3 years of relevant R&D experience or training.
  • Understanding of IVD development, including Design Controls, Quality System Regulations and ISO 13485, MDSAP, and IVDR requirements.
  • Understanding of immunohistochemistry and in situ hybridization protocols and assays.
  • Ability to work independently with minimal supervision.
  • High attention to detail.
  • High level of verbal and written communication and an ability to effectively present complex information.
  • Effective use of Microsoft Office programs.
  • Effective use of Project Management tools.
  • Demonstrates organization and good housekeeping habits.

Compensation Range

  • $67,000 - $75,000 annually

Expected Hours of Work

  • 8:30 a.m. to 5:30 p.m. Monday Friday (unless otherwise determined by departmental needs that may include earlier or later starting and ending hours. ). 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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