QC Analyst II/III-Histology
150 Dan Road, Canton, Massachusetts, 02021, United States
Job Req code 613
Category: Quality
About Us
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.
Learn more about Careers at Organogenesis
What You Will Achieve:
The QC Analyst II/III performs advanced quality activities in support of product production and releases with moderate/minimal supervision. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst II/ III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires repetitive hand movement e.g., microtomy, use of biopsy punch, and keyboard use for moderate or long periods of time.
This position requires flexibility to work some holidays and occasional 3rd shift as needed to support critical final product release.
How You Will Achieve It:
- Primary responsibility for the day-to-day activities in the Histology laboratory in support of material and product release testing.
- Morphological evaluation for release of final product and/or process development samples
- Scientific/technical contributor on cross-functional projects related to Histology activities and assay development/optimization.
- Interact and coordinate with Manufacturing and QA Operations daily.
- Tracking sample receipt.
- Execute assigned tasks with minimal supervision.
- Donated tissue receipt and transfer.
- Identify and report areas for process improvement.
- Generate and execute feasibility/validation protocols.
- Generate trend reports as they relate to quality testing.
- Work closely with team members to ensure timely release of materials.
- Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
- Assist with inter-departmental interactions to ensure customer service needs are satisfied and priorities understood.
- Identifies and implements issues and opportunities for improvements.
- Revise/Create SOPs.
Requirements
What You Need to Achieve It:
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TEST REQUIREMENTS
Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards.
What can we offer you?
- 401k -- generous employer match with immediate vesting and financial planning resources
- Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
- Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
- Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
- Paid maternity leave and parental leave for all new parents
- Adoption benefits
- Education Assistance Policy - $5,000 per year for all employees
- Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
- Employee Assistance Program
- Generous paid time off including vacation, floating holidays, sick days, and company holidays
- Free parking including an electric charging station (Canton and La Jolla)
- Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.
We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.