Quality Assurance Specialist III

Profile

This Quality Specialist III is responsible to provide Quality Assurance support for GMP Manufacturing. Responsibilities include providing oversight of validation of GMP equipment, preventative maintenance, and calibration as well as QA leadership overseeing Deviations and CAPAs.  Provide internal and external audit leadership to maintain phase appropriate GMP manufacturing of biological products.  Support environmental and personnel monitoring systems within cleanroom and controlled spaces to ensure compliance with applicable regulatory and industry standards.  Identify quality improvements and efficiency within the manufacturing facility.

Principal Duties and Responsibilities: 

• Provides QA support to and quality oversight of GMP operations for the manufacture of drug product used in clinical trials and for commercial use.
• Review and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).  
• QA support for validation function, reviewing and approving applicable procedures, policies, plans, protocols & reports. 
• Quality oversight of suppliers and service providers to meet Talaris requirements, including independently conducting audits
• Conduct audits of manufacturing and support areas for adherence to internal procedures and industry best practices
• Quality oversight of preventive maintenance and calibration programs
• Support the review and approval of incoming raw materials
• Write, revise, and approve GMP documentation as necessary
• Lead site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
• Work cross-functionally with Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
• Support regulatory (i.e. FDA, EMA) audits/inspections 
• Performs other duties as assigned

Minimum Education, Training, and Experience Required: 

• Bachelor’s degree in a Life Sciences discipline; Master’s degree is a plus.
• 7 years’ experience within the biologic, biopharmaceutical, or regulated medical industry
• 4 years’ experience in Quality Assurance/Quality Control function
• Working knowledge of Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s as well as USP and ICH Guidelines.  
• Familiarity with 21 CFR Part 1271 and ATMP regulations is a plus.
• Knowledgeable of GMP manufacturing processes, particularly for biological or cell and gene therapy products.
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Familiarity with use of methodologies like six sigma and Kaizen to improve process/product quality is a plus. 
• Detail oriented team player with effective planning, organization and execution skills. 
• Excellent verbal and written communication skills. 
• Strong computer skills with Word and Excel; experience with E-Systems is preferred. 
• Ability to work effectively at a fast pace with cross functional departments. 
• Innovative, proactive, and resourceful; committed to quality and continuous improvement. 

Physical Requirements: 

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 15 pounds at times.  
• Must be able to access and navigate each department at the organization’s facilities. 

Benefits:

• Medical / Dental / Vision Insurance
• Company Paid Long & Short Term Disability
• 25 Days Paid Time Off 10 Paid Company Holiday’s
• 401k with Employer Contribution
• Stock Options and Restricted Stock Units (RSUs) 
• Paid Parental Leave
• Employee Stock Purchase Plan (ESPP)
• Generous Professional Development Policy for Job-Related External Learning Opportunities
• Employee Assistance Program (EAP)

 

**MEMBERS ONLY**SIGN UP NOW***. requires that all employees be fully vaccinated for COVID-19. Proof of vaccination or sincerely held religious belief and/or medical exemption is required upon hire. **MEMBERS ONLY**SIGN UP NOW***. will engage in an interactive dialogue process with employees who have documented medical conditions and/or sincerely held religious beliefs that would prevent them from getting vaccinated, in accordance with all applicable laws.

About Us: **MEMBERS ONLY**SIGN UP NOW***., Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders.  In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.

Equal Employment Opportunity: **MEMBERS ONLY**SIGN UP NOW***. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by emailing us at ****. When emailing, please include a description of your requested accommodation, your name and contact information.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: **** target=_blank rel=no-follow>****. 

,identifier:{name:**MEMBERS ONLY**SIGN UP NOW***.,value:1072,@type:PropertyValue},datePosted:2022-03-03T03:19:24 00:00,validThrough:2022-04-02T03:59:59 00:00,employmentType:FULL_TIME,hiringOrganization:{name:**MEMBERS ONLY**SIGN UP NOW***.,@id:2057616,url:****KY,address:{addressCountry:US,addressLocality:Kentucky,addressRegion:Kentucky,postalCode:40202,@type:PostalAddress},@type:place},industry:Clinical, Clinical Medicine, Quality,workHours:Full time,educationRequirements:Bachelors Degree,@type:JobPosting,@context:****

Company info

Sign Up Now - QAQCCrossing.com