Jobs in Westborough, MA
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Low cost job training - healthcare, tech, business, and more
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Find top-rated training programs near you with Dreambound
The #1 platform to find career training
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Low cost job training - healthcare, tech, business, and more
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Flexible payment options
Find top-rated training programs near you with Dreambound
The #1 platform to find career training
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Low cost job training - healthcare, tech, business, and more
Make more money in just a few months
Financial aid for those who qualify
Flexible payment options
Find top-rated training programs near you with Dreambound
The #1 platform to find career training
Fully online and evening classes available
Low cost job training - healthcare, tech, business, and more
Make more money in just a few months
Financial aid for those who qualify
Flexible payment options
Find top-rated training programs near you with Dreambound
The #1 platform to find career training
Fully online and evening classes available
Low cost job training - healthcare, tech, business, and more
Make more money in just a few months
Financial aid for those who qualify
Flexible payment options
Find top-rated training programs near you with Dreambound
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Job Title: QC Microbiology, Analyst I
Location: Westborough, MA
Zip Code: 01581
Duration:6 Months
Pay Rate: $33.33/hr
Keyword's: #Westboroughjobs; #Microbiologyjobs.
Start Date: Immediate
Job Description:
Essential Job 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 non conformances 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.
Required:
* 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
Preferred:
* 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.
WHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
· Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
· Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
· Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
· Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
· Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
· Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
· Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
· Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
· Bachelor’s degree in Biology (Microbiology)
· 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
· Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
· Excellent/Effective written and verbal communications skills.
· Prepare technical data and present to senior leadership.
· Escalate issues professionally and on a timely basis.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
