Current jobs related to Sr. Associate II, Quality Assurance - Triangle Township - Biogen

  • Senior Quality Assurance Associate

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Associate to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Ensure compliance with regulatory requirements and site procedures.Assess criticality of exceptions...

  • Quality Assurance Tech

    2 months ago

    Pennsauken Township, United States PeopleShare Full time

    Job Title: QA Tech IILocation: Pennsauken, NJPay Range: $23.90 - $24.90 per hourSchedule/Hours: 2-2-3 rotating shifts, 6:00 PM - 6:00 AMJob Description:We are currently seeking a detail-oriented QA Tech II to join our team. The QA Tech II will play a critical role in ensuring the safety and quality of our products through meticulous inspection, testing, and...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Systems team at Biogen. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining GMP activities at our RTP facility.Key Responsibilities:Manage regulatory and partner inspections, including inspection...

  • Quality Assurance Associate

    1 month ago

    Cranberry Township, United States SSi People Remote Work Freelance Full time

    Shift Hours: 8:30am-5pmJob DescriptionThe Operations Quality Assurance Associate I will evaluate work completed by Operations agents against program SOPs, WINs, business rules, and other program-related documents for adherence to expectations outlined in the documents.The QA Associate I must be able to use objective decision-making and critical thinking...

  • Quality Assurance Specialist

    3 weeks ago

    West Bloomfield Township, Michigan, United States Kaman Full time

    Job SummaryWe are seeking a skilled Quality Assurance Specialist to join our team at Kaman. The successful candidate will be responsible for performing visual and dimensional inspections of mechanical components and assemblies to close tolerance.The ideal candidate will have 1+ years of manufacturing inspection experience and be proficient in CMM operations...

  • Senior Quality Associate I

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryThis role will contribute to key strategic, tactical, and operational aspects within Quality Assurance at Biogen's Research Triangle Park (RTP) Drug Product Parenteral Facility.Key ResponsibilitiesEnsure product documentation and other documents supporting batch execution are compliant and determine acceptability for use in cGMP production...

  • Sr. Associate QA Analyst

    3 months ago

    Moon Township, United States MCKESSON Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.What you do at McKesson matters. We foster a culture...

  • Test Technician II

    1 month ago

    West Bloomfield Township, Michigan, United States II-VI Incorporated Full time

    We are seeking a skilled Test Technician to join our team at II-VI Incorporated in Bloomfield, CT. This role requires individuals who thrive in a fast-paced, technically demanding environment with a focus on high-power CO2 lasers.Key Responsibilities:Work on assignments that involve recognizing deviations from accepted practices and applying technical...

  • Validations Contractor

    2 weeks ago

    Research Triangle Park, United States TalentBurst, Inc. Full time

    Validations - GMP Quality Assurance Engineer, Research Triangle Park, NC6 months+Description:The Validations Contractor – GMP Quality Assurance, reporting to the Director, GMP Quality Assurance, will be responsible for assisting in the management of Quality Management System (QMS) and will strongly support the Culture of Quality. This role will ensure...

  • Quality Assurance Manager

    4 weeks ago

    Cranberry Township, United States LHH Recruitment Solutions Full time

    Job Title: Quality Assurance ManagerLHH Recruitment Solutions is seeking an experienced Quality Assurance Manager to lead and develop our Clients Quality Assurance Department in the Cranberry Twp, PA area. This role involves fostering communication to drive quality improvements and collaborating closely with the production team to ensure defect-free...

  • Quality Assurance Specialist

    3 weeks ago

    Branchburg Township, United States Synectics Inc Full time

    Job DescriptionAt Synectics Inc, we are seeking a highly detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality control department, you will be responsible for reviewing batch records to ensure compliance with all specified requirements and procedures.Key Responsibilities:Review batch records for compliance with GMP...

  • Test Technician II

    2 months ago

    West Bloomfield Township, Michigan, United States II-VI Incorporated Full time

    {"Job SummaryWe are seeking a skilled Test Technician to join our team at II-VI Incorporated. This role requires individuals who thrive in a fast-paced, technically demanding environment and are passionate about working with high-power CO2 lasers.Key Responsibilities* Work on assignments that involve recognizing deviations from accepted practices and taking...

  • Quality Assurance Specialist

    4 weeks ago

    Branchburg Township, United States AbbVie Full time

    {"Job Title": "Quality Assurance Analyst", "Job Description": "Job OverviewAbbVie is seeking a Quality Assurance Analyst to support the activities and initiatives of the Quality Manager to implement and manage the Quality System.Key ResponsibilitiesImplement and maintain the effectiveness of the quality systemProvide effective quality controls to the...

  • Quality Assurance Manager

    1 month ago

    Cranberry Township, United States LHH Full time

    LHH Recruitment Solutions is looking for an experienced Quality Assurance Manager to lead and develop our Clients Quality Assurance Department in Cranberry Twp, PA area. This role involves fostering communication to drive quality improvements and collaborating closely with the production team to ensure defect-free products. The QA Manager will also oversee...

  • Quality Assurance Specialist

    4 weeks ago

    Branchburg Township, United States AbbVie Full time

    Job SummaryAbbVie is seeking a Quality Assurance Analyst to support the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on policy & procedure, program management, patient record review, internal/external audit, and metrics and trend analysis and reporting.Key ResponsibilitiesImplement and...

  • Quality Assurance Manager

    1 month ago

    Cranberry Township, United States LHH Recruitment Solutions Full time

    Job DescriptionJob DescriptionLHH Recruitment Solutions is looking for an experienced Quality Assurance Manager to lead and develop our Clients Quality Assurance Department in Cranberry Twp, PA area. This role involves fostering communication to drive quality improvements and collaborating closely with the production team to ensure defect-free products. The...

  • Quality Assurance Administrator

    4 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Quality Engineering AdministratorKamatics Corporation is seeking a highly motivated and detail-oriented Quality Engineering Administrator to join our Quality team at our Bloomfield, CT facility. As a key member of our Quality Assurance team, you will be responsible for handling various administrative tasks involving supporting documentation for our parts and...

  • Quality Control Technician

    2 weeks ago

    Pennsauken Township, United States PeopleShare Full time

    Job Title: Quality Control Technician Location: Pennsauken, NJ 08110Pay Range: $23.90 - $24.90 per hourSchedule/Hours: 2-2-3 rotating shifts, 5:45 PM - 6:00 AMJob Description:We are currently seeking a detail-oriented QC Tech II to join our team. The QC Tech II will play a critical role in ensuring the safety and quality of our products through meticulous...

  • Quality Assurance Manager

    3 weeks ago

    Mt Laurel Township, NJ, USA, United States Syntricate Technologies Full time

    Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Syntricate Technologies. As a Quality Assurance Manager, you will be responsible for managing multiple projects and coordinating with System analysts/Dev team/Architects to ensure that requirements are met and translated into testable units for the QE team...

  • Quality Assurance Specialist

    4 weeks ago

    Charter Township of Brownstown, United States Allegiance Staffing Full time

    Job SummaryAllegiance Staffing is seeking a Quality Assurance Specialist to join our team in Auburn Hills. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by inspecting output samples, reviewing blueprints and specifications, and recording inspection results.Key ResponsibilitiesInspecting output samples...

Sr. Associate II, Quality Assurance

2 months ago

Triangle Township, United States Biogen Full time
Job DescriptionJob DescriptionJob Description

About This Role  

This is a full time on-site position

The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.  The Sr. Associate II has an advanced understanding of QC Microbiology laboratory, testing, and Annex I requirements.  Additionally, this individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures. This individual will assist with regulatory and third party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives.

 

What You’ll Do  

  • Ensure Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and /or distribution.   
  • Serve as a highly skilled technical consultant for quality related issues and assure compliance with regulatory requirements and site procedures. 
  • Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of investigations and determine potential areas within the process that may have attributed to the exception. 
  • Review documents for compliance and identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.  
  • Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business.  
  • Mentor and train less experienced associates across Quality Assurance functions. Serve as a technical subject matter expert (SME) in support of department functions.
  • Additional job duties as assigned.
Qualifications

  • Bachelor’s Degree required, preferred in Microbiology or life science
  • Minimum 5 years of relevant Quality experience
  • Experience working in a pharmaceutical or biotech manufacturing environment
  • Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
  • Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
  • Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes and decisions

Highly Preferred Skills 

  • Competencies in QC Microbiology, QC Microbiology laboratory, testing, and Annex I requirements


Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.