Quality Control Microbiologist

4 days ago

Marlborough, Massachusetts, United States SPECTRAFORCE Full time

Position Title:
QC Microbiology Analyst I

Work Location:
Marlborough, MA 01581

Assignment Duration:
06 months

Work Schedule:
Standard work week (M-F) with flexibility of weekend work

Work Arrangement:
On-site

Position Summary:
Support Quality Control Microbiological testing of drug substances, raw materials, and process intermediates under cGMP and GLP guidelines, address excursions, and conduct investigations.

Key Responsibilities:

  • Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
  • Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
  • Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
  • Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
  • Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.
  • Author/update laboratory procedures, protocols, and help in EM data trend reports.
  • Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
  • Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.
  • Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.

Qualification & Experience:

  • B.S. degree in Biology or other life science related degree with 0-3 years of relevant industry experience in a quality control role.
  • While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience.
  • Excellent knowledge of Aseptic technique and common microbiological testing.
  • Knowledge of relevant, compliance and guidance documents.
  • Must be able to gown into cleanrooms in support of testing and manufacturing activities.
  • Good documentation (ALCOA +) and data organization.
  • Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.
  • Interpersonal skills and ability to contribute to the success of a team.
  • Proven history of working in a fast-paced team environment, time management, and meet deadlines.
  • Team player with the ability and willingness to support other colleagues in the Quality Control department.
  • This support may include future cross training with analytical assays as needed.
  • Models our Core Values: Bold, Caring, and Results-Driven — consistently exemplifies the culture we strive to create, operates with transparency, and earns trust.

  • Sr. Quality Systems Engineer- Global Design Controls

    4 days ago

    Marlborough, Massachusetts, United States bostonscientific Full time

    Recruiter: Spencer Gregory HaleSenior Quality Systems Engineer- Global Design Controls & Labeling About the role:BSC is re-imagining the way our products are sourced, manufactured, packaged, shipped and distributed. This new approach will allow us to manufacture more products and reliably deliver them to customers, while making our supply chain more...

  • Manager Quality, Operations

    5 days ago

    Marlborough, Massachusetts, United States Sartorius Full time

    Sartorius is seeking a Manager, Quality Operations, to join our team in delivering high-quality products to customers worldwide.As the Manager, Quality Operations, you will play a key role in upholding product quality standards and collaborating across departments to ensure operational excellence.  In this role, you will oversee manufacturing quality...

  • Quality Engineer II

    7 days ago

    Marlborough, Massachusetts, United States Randstad USA Full time

    Start: 2-3 weeks from date of offerLocation: Marlborough, MA - OnsiteLength of Contract: 12 monthsHourly Pay: 44-55 p/hr - W2*W2 Contract Only**Background check**No 3rd Party Vendors / Candidates*Job Summary:This position provides support to the Global Supplier Quality organization dedicated to the oversight of components, other materials & services. He/she...

  • RCI-HOLX-1495 Quality Engineer

    5 days ago

    Marlborough, Massachusetts, United States Rangam Full time

    Must be onsiteRequired Skills & Experience-:2–3 years preferred; 5+ years considered overqualified –Background : Regulated industry (preferably medical devices) –Must-Haves: ISO 13485, CFR Part 820, CAPA and root cause analysis, IQ/OQ/PQ EducationRequirement : Degree in Electric/Mechanical engineering (Candidates with Industrial/Chemical engineering...

  • Post Market Quality Engineer

    2 weeks ago

    Marlborough, Massachusetts, United States Hologic Full time

    Product Quality Engineer – Breast and Skeletal Health DivisionLocation: Marlborough, MA (Hybrid )Are you passionate about driving product quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division as a Post Market Quality Engineer and play a pivotal role in supporting on-market...

  • Senior Product Quality Engineer

    2 days ago

    Marlborough, Massachusetts, United States Hologic Full time

    DescriptionAre you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and...

  • Senior Product Quality Engineer

    4 days ago

    Marlborough, Massachusetts, United States Hologic Careers Full time $97,600 - $152,700

    Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive...

  • Design Quality Engineer

    20 hours ago

    Marlborough, Massachusetts, United States CardioFocus Full time

    COMPANY OVERVIEWThrough ongoing research and development, we provide physicians with access to state-of-the-art technologies for managing complex cardiac arrhythmia.Our innovative solutions utilize customized Pulse Field Ablation waveform design for precise and effective treatment of atrial fibrillation.Our designs enable shorter procedure times for...

  • Sr. Director, Design and Supplier Quality

    1 week ago

    Marlborough, Massachusetts, United States Candela Medical Full time

    Company Overview:Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are the market leader in the development, and distribution of medical and aesthetic laser and light-based technologies. The Company's technology enables physicians to provide advanced solutions for a...

  • Quality Engineer 2

    3 days ago

    Marlborough, Massachusetts, United States Hologic Full time

    Are you passionate about ensuring the highest quality standards for life-saving medical devices? At Hologic, we are seeking a Quality Engineer II to drive compliance, risk management, and continuous improvement across our product lifecycle. In this role, you'll collaborate with cross-functional teams to lead investigations, implement corrective actions, and...