QC Associate II, Raw Materials

3 weeks ago

Westborough, Massachusetts, United States Astellas Pharma Full time

Job Summary:

Astellas Pharma Inc. is seeking a highly motivated Quality Control Specialist II, Raw Materials to join our team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

This role provides Quality Control compliance and release testing of raw materials used in the manufacture of Astellas cell therapy products in accordance with GDP/GMP guidelines.

Key Responsibilities:

  • Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures.
  • Perform validation/verification of analytical methods used in RM testing.
  • Provide support and oversight of laboratory equipment, computer systems and PM/calibration program to ensure on-time testing completion.
  • Perform author and review of data, SOPs, qualification plans, specifications and technical reports as needed to ensure compliance with Good Manufacturing Practices (GMP).
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.
  • Support the shipment of samples to approved contract laboratories for testing.
  • Maintain adequate inventory of supplies needed for all raw material sampling and testing.
  • Ensure data integrity of all generated quality control data from QCRM laboratory function.
  • Review raw data and results from contract laboratories for raw materials testing.
  • Ensures all tasks are performed in a manner consistent with safety standards.
  • Participate in audits (internal / external) where necessary (prep, support, interactions) related to QC processes and RM program.
  • Perform QC lab duties and technical projects as required.

Requirements:

  • B.S. degree in Biology/ or other life science related degree with 3 + years of relevant industry experience in a quality control role.
  • MS with 0-2 years of laboratory experience.
  • Knowledge of GMP, SOP's and quality control process.
  • Strong written and verbal communication skills.
  • Ability to work weekends while rare, may be required.
  • Understanding of quality operations with ability to troubleshoot and solve technical problems. Independently contribute to the development of new testing methods. Continues to take on more responsibility to provide content for various documents and reports. Increasing ability to execute protocols and summarize results with limited guidance.

Preferred Qualifications:

  • Experience with ICH, USP, EP and JP guidelines for test methods.
  • Experience with 21CFR Part 11 Compliance.
  • Good documentation, data organization, Detail oriented, and willingness to learn.
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.
  • Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
  • Models our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and compliance.

Benefits:

  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • 401(k) match and annual company contribution
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Referral bonus program

  • QC Associate II, Raw Materials Specialist

    3 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Our team is driven to develop and deliver innovative and effective new medicines to patients and physicians.We are...

  • QC Associate II, Raw Materials Specialist

    3 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Job Summary:Astellas Pharma Inc. is seeking a highly motivated Quality Control Analyst II, Raw Materials to join our team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.This role provides Quality Control compliance and release testing of raw materials used in the manufacture of Astellas cell therapy products in accordance...

  • Quality Control Specialist

    3 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Quality Control Associate Job DescriptionAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Keeping our focus on addressing unmet medical needs and conducting our business...

  • Quality Control Associate II, Analytical Position

    4 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Job Summary:Astellas Pharma Inc. is seeking a highly motivated Quality Control Associate II, Analytical to join our team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.Key Responsibilities:Perform routine in-process and release QC testing of AIRM cell products.Execute GMP analytical assays such as Immunofluorescence, Flow...

  • Quality Control Specialist II, Analytical

    3 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Quality Control Associate II, Analytical Job DescriptionAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Keeping our focus on addressing unmet medical needs and...

  • Quality Assurance Specialist

    4 weeks ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Job SummaryAstellas Pharma Inc. is seeking a Quality Assurance Specialist to join their team at the Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.The successful candidate will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization.This role will...

  • Technical Writer II Position

    4 weeks ago

    Westborough, Massachusetts, United States Ursus, Inc. Full time

    Job Title: Technical Writer IIThe Mechatronics & Sustainable Packaging Customer Experience organization at Ursus, Inc. is seeking an experienced Technical Writer II to create high-quality technical documentation for automated/robotics technologies. The ideal candidate will have a strong background in instructional design, adult learning principles, and...

  • Material Handler

    3 weeks ago

    Westborough, Massachusetts, United States TalentBurst Full time

    Job Title:Service Technician/Machine OperatorLocation:Westborough, MADuration:9 MonthsShift Timing:2nd shift 03:00 pm -11:30pmJob Description:Schedule: Training for the first month will be 6:15am2:45 pm and will then switch to 2nd shift 3pm-11:30pm for the remainder of the contract.Are you inspired by invention? Is problem solving through teamwork in your...

  • Maintenance Technician II

    3 weeks ago

    Westborough, Massachusetts, United States C&W Services Full time

    About the RoleC&W Services is the industry leader in Integrated Maintenance Solutions, providing service to more than 600 companies worldwide and a sister company of Cushman & Wakefield.We offer:Weekly PayComprehensive Benefits that start on your first dayAdvancement OpportunitiesTraining to work in a Cutting Edge FacilityA Safety First...

  • Mechanical Engineer II

    4 weeks ago

    Westborough, Massachusetts, United States Coghlin Companies Inc Full time

    Job SummaryWe are seeking a highly skilled Mechanical Engineer II to join our team at Coghlin Companies Inc. As a key member of our engineering team, you will be responsible for designing, developing, and implementing mechanical systems and components for our clients.Key ResponsibilitiesDefine mechanical engineering design requirements and develop...

  • Loan Servicing Specialist II

    4 weeks ago

    Westborough, Massachusetts, United States Westborough Operations Center Full time

    Job SummaryWe are seeking a highly skilled Loan Servicing Specialist II to join our team at the Westborough Operations Center. This role is responsible for performing a variety of loan servicing and processing activities in conformance with established bank policies, procedures, and objectives.Key ResponsibilitiesSet up new loans for commercial, construction...

  • Loan Servicing Specialist II

    4 weeks ago

    Westborough, Massachusetts, United States Westborough Operations Center Full time

    Job SummaryWe are seeking a highly skilled Loan Servicing Specialist II to join our team at the Westborough Operations Center. As a key member of our Commercial Loan Servicing team, you will be responsible for performing a variety of loan servicing and processing activities in conformance with established bank policies, procedures, and objectives.Key...

  • Document Control Coordinator II

    4 weeks ago

    Westborough, Massachusetts, United States Olympus Corporation of the Americas Full time

    Job DescriptionAs a Document Control Coordinator II at Olympus Corporation of the Americas, you will play a critical role in supporting the coordination and processing of documentation changes. This position requires a strong understanding of quality change management processes and experience with MRP ERP PLM systems.Key Responsibilities:Support all release...

  • Mechanical Engineer II, Robotics Storage Technology Specialist

    4 weeks ago

    Westborough, Massachusetts, United States Amazon Full time

    Job OverviewAs a Mechanical Engineer II at Amazon Robotics, you will play a key role in developing innovative system architectures and hardware designs for our robotic systems. This is a unique opportunity to work with a talented team of engineers and contribute to the creation of cutting-edge robotics solutions.Key ResponsibilitiesCollaborate with an...

  • Warehouse Associate

    4 weeks ago

    Westborough, Massachusetts, United States Eastridge Full time

    Job SummaryEastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. We are urgently hiring a Material Handler for a leading provider of engineering and contract manufacturing services. Under direct supervision, the Material Handler will perform...

  • Facilities Associate

    3 weeks ago

    Westborough, Massachusetts, United States Ocean State Job Lot Full time

    Job Summary: We are seeking a highly motivated and detail-oriented Facilities Associate to join our team at Ocean State Job Lot. As a Facilities Associate, you will be responsible for maintaining a clean, safe, and functional store environment, ensuring a positive customer experience.Key Responsibilities:Maintenance and Safety: Identify and correct...

  • Shipping Associate I

    4 weeks ago

    Westborough, Massachusetts, United States NEO Tech Full time

    Job Summary:NEOTech is seeking a highly organized and detail-oriented Shipping Associate I to join our team at our Westborough, MA manufacturing site. As a key member of our shipping team, you will be responsible for assembling orders, preparing goods for shipment, and ensuring timely delivery to our customers.Key Responsibilities:Assemble orders and prepare...

  • IT Support Specialist

    4 weeks ago

    Westborough, Massachusetts, United States Connection Full time

    IT Support Technician IIAt Connection, we're seeking a skilled IT Support Technician II to join our team in Westborough, MA. As a key member of our Technical Services division, you'll be responsible for providing front-line support to our end-users, troubleshooting and resolving issues on Windows computers, iPhone, desktops, and tablets.Key...

  • Quality Assurance Specialist

    4 weeks ago

    Westborough, Massachusetts, United States Coghlin Companies Full time

    Job SummaryColumbia Tech is a leading provider of Time to Market Services, offering product development, manufacturing, global fulfillment, and aftermarket services to innovation leaders in various industries. As a Quality Engineer I, you will play a critical role in ensuring best-in-class quality for our products and providing seamless communication between...

  • Applications Administrator II

    4 weeks ago

    Westborough, Massachusetts, United States cumberlandfarmsinc Full time

    Job SummaryThe Applications Administrator is a critical role within our organization, responsible for the strategic implementation, maintenance, and optimization of POS systems. This position requires a strong focus on maintaining system integrity, security, and compliance with relevant regulations.Key ResponsibilitiesProvide Tier 2 and 3 application support...