QC Analyst III - Microbiology

100 Technology Way, Smithfield, Rhode Island, United States

Job Req code 524

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.

 

What You Will Achieve:

The QC Analyst III performs complex quality activities in support of product production and releases.  The position has interaction with other internal departments including, Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position also has interaction with external entities including contractors and suppliers. The QC Analyst III performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. Holiday work required on rotating basis.

 

How You Will Achieve It:

  • Perform raw material, intermediate and non-routine testing
  • Perform endotoxin, microbiologic, and water testing
  • Perform reading environmental, personnel, and in-process sterility testing
  • Prepare and send out samples for microbiological identification and/or mycoplasma testing
  • Perform visual inspection of final product
  • Generate complex trend reports as they relate to quality testing
  • Revise SOPs
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
  • Participate extensively in high-level quality systems programs (CAPA, etc.).
  • Provide input into failure investigations
  • Participates, contributes, and adds value in cross- functional settings.
  • Collaborates and communicates appropriately in all situations.
  • Looks for ways to reduce errors and costs.
  • Takes ownership for meeting all deliverables. 
  • Responsible for initiating, investigating, and closing environmental monitoring excursion reports
  • Supporting preparation and adjustments to weekly schedule
  • Fast-paced high energy team-oriented work environment
  • Preparing and setting up the QC Micro laboratory to operational readiness

Requirements

What You Need to Achieve It:

  • Requires a Bachelor’s Degree in Microbiology or related field
  • Minimum of 5-7 years of Microbiology experience in a GMP/Medical Device/ Pharmaceuical or Biological regulated environment
  • Experience in Aseptic Processing is preferred

 

Physical Requirements:

  • This position may require a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K.
  • This position may require 2-3 hours of standing per day with frequent stooping and lifting

 

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 a Level II role is $68,000-$81,000 and for a Level III is $81,000-$95,000 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.  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.