<p>About Us</p> <p>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.</p> <p>Learn more about Careers at Organogenesis</p> <p>What You Will Achieve:</p> <p>The QC Analyst III is responsible for the performance and reporting of analytical testing in support of product production and release, as well as developmental assays, as required. The QC Analyst III helps provide delivery of compliant laboratory systems and data in support of Organogenesis products, and in accordance with appropriate regulatory, corporate and scientific guidelines.</p> <p>In addition, the QC Analyst III will also provide input in support of method validation, cleaning validation, process validation, and characterization activities. In this position, the QC Analyst III will also interact with external entities including contractors and suppliers.</p> <p>How You Will Achieve It:</p> <ul> <li>Perform chemical analysis and ELISA assays for raw materials, intermediates, and finished product testing. </li><li>Demonstrate knowledge in analytical test methods to support in-process, raw materials, and routine final product test samples. </li><li>Prepare and send out samples for testing, when necessary. </li><li>Perform visual inspection of finished product. </li><li>Generate trend reports, as they relate to Quality testing. </li><li>Author and revise SOPs. </li><li>Identify and implement issues and opportunities for improvements. </li><li>Participate extensively in high-level quality systems programs (CAPA, etc.). </li><li>Interact with Manufacturing and other departments to ensure support of processes and product testing. </li></ul> <p>Job Requirements</p> <p>What You Need to Achieve It:</p> <p>*</p> <ul> <li> <p>BS in a relevant scientific discipline (i.e., Chemistry, Biology, Biochemistry)</p> </li><li></li><li> <p>5+ years of experience in a cGMP Quality Control Department in a FDA-regulated industry.</p> </li><li> <p>In-depth knowledge of compendial (USP, EP) test methods, and relevant ICH and FDA guidelines</p> </li><li> <p>Technical and Scientific Proficiency</p> </li><li> <p>Proven technical proficiency and demonstrated skills in quality technology practices.</p> </li><li> <p>Demonstrates understanding of relatively complex data with proficiency to problem solve.</p> </li><li> <p>Data Analysis Requirements</p> </li><li> <p>Proficient in the use and application of quality tools, databases, and process skills.</p> </li><li> <p>Regulatory Requirements</p> </li><li> <p>Advanced knowledge of relevant Quality System and SOP procedures. Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and Regulatory standards.</p> </li><li> <p>Advanced understanding of corporate documentation standards (SOP) and the interrelationship of SOPs and the functional areas.</p> </li><li> <p>Ability to work independently on complex assignments and exercise sound judgment under minimal supervision.</p> </li><li> <p>Ability to analyze non-conformance issues, recommend corrective action, and ensure compliance with company and Regulatory requirements.</p> </li><li> <p>Ability to act independently and determine methods and strategies for addressing and documenting issues during product testing.</p> </li><li> <p>Demonstrated strong leadership and communication skills.</p> </li><li> <p>Ability to establish strong working relationships and work collaboratively in a team environment.</p> </li><li> <p>Background in handling OOS, retest, and stability testing.</p> </li><li> <p>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.</p> </li></ul> <p>What can we offer you?</p> <ul> <li>401k -- generous employer match with immediate vesting and financial planning resources </li><li>Comprehensive Medical, Dental and Vision coverage options effective on day one of employment </li><li>Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account </li><li>Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options </li><li>Paid maternity leave and parental leave for all new parents </li><li>Adoption benefits </li><li>Education Assistance Policy - $5,000 per year for all employees </li><li>Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more </li><li>Employee Assistance Program </li><li>Generous paid time off including vacation, floating holidays, sick days, and company holidays </li><li>Free parking including an electric charging station (Canton and La Jolla) </li><li>Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint </li></ul> <p>The anticipated annualized base salary is $81,000-$97,000 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.</p> <p>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.</p> <p>Physical Required</p> <p>Job Type</p> <p>Full-time</p> <p>Location</p> <p>Organogenesis Rhode Island - Smithfield, RI US (Primary)</p> <p>Education</p> <p>Bachelor's Degree</p> <p>Career Level</p> <p>Individual Contributor</p> <p>Travel</p>