QC Analytical Supervisor

Description

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About Us

We are a leading regenerative medicine company in the advanced and acute wound care space 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 strength is giving others strength.

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space 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 strength is giving others strength.

What You Will Achieve:

This position is responsible for providing leadership, supervision and delivery of compliant laboratory systems and data in support of Organogenesis products, and in accordance with appropriate regulatory, corporate and scientific guidelines. This position manages the QC analytical operations. In addition, this position provides oversight of studies in support of method validation, cleaning validation, process validation, and characterization activities.

How You Will Achieve It:

• Preparing and setting up the QC analytical laboratory to operational readiness.
• Supervises direct reports and schedules testing, and lab functions to meet crucial timelines.
• Ensures the lab activities are conducted in compliance with all relevant regulatory and compendial guidance.
• Demonstrates extensive knowledge in analytical test methods to support in-process, raw materials, and routine final products test samples.
• Interacts with Manufacturing and other departments to ensure support of processes and product testing.
• Performs and/or assists with laboratory testing, as needed.
• Interacts with clients during audits as a subject matter expert for QC Analytical.
• Oversee, reviews, and approves test results in a timely manner.
• Authors SOPs, OOS, deviations, trend reports, excursion reports and other quality system reports, as required.
• Oversees CoA generation of batch records.
• Supports batch record review.
• Reviews and approves testing results/documentation generated by the laboratory or is responsible and accountable for delegating this review appropriately to associates. Ensures all operations are performed with 100% compliance to cGMP/ISO documentation standards.
• Assesses procedural deviations and Out of Specification/Aberrant laboratory incidents, including providing recommendations and implementing corrective/preventative actions. Promptly conducts investigations of unexpected test results to meet testing deadlines.
• Establishes training requirements: develops, administers, and monitors the training program, maintains records in compliance with corporate and industry standards, and ensures a safe work environment.

What You Need to Achieve It:

• Required Education: BS in a relevant scientific discipline (Chemistry, Biology, Biochemistry)
• Work Experience: 5 years of experience in a cGMP Quality Control department in a FDA regulated industry and at least one year of supervisory experience
• In-depth knowledge of compendial (USP, EP) test methods, and relevant ICH and FDA guidelines
• Ability to work independently on complex assignments and exercise sound QA judgment under minimal supervision.
• Ability to analyze non-conformance issues, recommend corrective action, and ensure compliance with company and FDA requirements.
• Ability to act independently and determine methods and strategies for addressing and documenting issues during product testing.
• Expertise in interpreting and applying evolving regulatory and Quality standards.
• Demonstrated strong leadership, communication, and employee coaching skills.
• Ability to establish strong working relationships and work collaboratively in a team environment.
• Background in handling OOS, retest, and stability testing.
• Competency in performing statistical analysis to evaluate and trend test data.
• Strong background with a broad range of analytical techniques.
• Experience in interacting with auditors from regulatory agencies.

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

The anticipated annualized base salary for this role is $98,000-$110,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. This position is also eligible to participate in the company’s annual management bonus plan. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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