Hollister Associate Job For BSc Biology & Biochem, Apply Online
Associate Biocompatibility & Toxicology Specialist
Hollister Global Business Services India Private Limited is a leading company in the medical device industry. We specialize in producing high-quality products that improve the lives of patients worldwide. As an Associate Biocompatibility & Toxicology Specialist, you will play a crucial role in ensuring our products meet the highest standards of biocompatibility and toxicology.
Position: Associate Biocompatibility & Toxicology Specialist / Scientist
Location: Gurgaon, HR, IN, 122002
Work Mode: Hybrid
Summary:
The Associate Biocompatibility & Toxicology Specialist / Scientist will be responsible for ensuring biocompatibility and toxicology related quality and regulatory compliance for all Hollister products. In this role, you will support Hollister’s biocompatibility and toxicology program, including the development and implementation of policies and procedures.
Responsibilities:
- Biocompatibility / Toxicology (Bio/Tox) Testing & Risk Assessment Knowledge / Capability – Base understanding of scientific methods, including chemistry, and ability to understand biocompatibility assessment methodology.
- Standards and Regulations Knowledge / Capability – Ability to interpret Bio/Tox standards
- Project Knowledge / Capability – Capability (with moderate guidance / support) to provide Bio/Tox related change control project support as well as support / provide guidance to lower-level associates.
- Product Knowledge / Capability – Basic knowledge related to Hollister product portfolio.
- Audit / Supplier Approval & Maintenance Knowledge / Capability – Capability (via audit support experience) to support Bio/Tox lab related supplier re-evaluations and external audits of Hollister (e.g. NSAI, FDA) with guidance.
- Complaint Management Knowledge / Capability – Capability to provides Bio/Tox support (with moderate guidance) to the complaint management process.
- Problem Solving Knowledge / Capability – Capability (with moderate guidance) to support solutions to root cause investigations for Bio/Tox laboratory test failures.
- Coaching & Mentoring Knowledge / Capability – Ability to receive and give feedback / guidance to lower-level associates.
- Quality Systems Knowledge / Capability – Demonstrated limited knowledge of medical device quality systems (via “functional support” experience associated with a single 3rd party internal audit).
- Regulatory Process Knowledge / Capability – Demonstrated limited support capability (via direct “functional support” experience regarding a Regulatory submission related to a single external body).
- Financial Acumen Knowledge / Capability – Limited understanding of financial analysis related to lab testing & Ability to learn Company Purchase Order system (e.g. COUPA).
Essential Functions of the Role:
- Provide Bio/Tox related change control project support as well as support / provide guidance to lower-level associates.
- Basic knowledge related to Hollister product portfolio.
- Support Bio/Tox lab related supplier re-evaluations and external audits of Hollister (e.g. NSAI, FDA) with guidance.
- Provide Bio/Tox support (with moderate guidance) to the complaint management process.
- Support solutions to root cause investigations for Bio/Tox laboratory test failures.
- Receive and give feedback / guidance to cross-functional and lower-level associates.
- Support Bio/Tox related 3rd party audits.
- Support Bio/Tox related Regulatory activity.
- Support budget compliance and submission of purchase orders to support Bio/Tox testing.
Essential Functions of the Role:
- Lifting – up to 25 lbs.
- Physical dexterity – typing, walking, standing and sitting.
- Ability to travel and drive.
Work Experience Requirements: Three (3) years of relevant experience in the medical device industry.
Education Requirements: Bachelor’s Degree in biology, biochemistry, toxicology, or similar discipline.
Specialized Skills/Technical Knowledge:
- Demonstrates core understanding of EN/ISO Sterilization Standards (i.e. ISO 10993 etc.).
- Knowledge in Quality Systems standards and FDA Medical Device Regulations (i.e., ISO 13485; QSR).
- Strong communication skills.
Work Mode and Location:
- Work Mode: Hybrid
- Location: Gurgaon
How to Apply: To apply for the position of Associate Biocompatibility & Toxicology Specialist, please click here.
Keywords: Associate Biocompatibility & Toxicology Specialist, Hollister job, Biology job, Biochemistry job, Gurugram job. Hollister Associate Job For BSc Biology & Biochem, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
