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Company Contact Info
- Cambridge, MA 02142
- Edmund Fisher
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Kelly Scientific Resources • Cambridge, MA
Posted 11 days ago
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Manufacturing Associate Level 1-5
Schedule: Daytime 7am – 7pm, rotating 2 days on, 2 days off and every other weekend
Overnight 7pm- 7am, rotating 2 days on, 2 days off and every other weekend
(Both daytime and overnight shifts are available)
Employment type: Non-exempt, both Contract-to-Permanent and Permanent openings available.
Kelly Scientific is helping their premiere client in Cambridge MA in hiring all levels of Bioprocessing/Manufacturing Associates in a mid-size pharmaceutical setting! The Manufacturing Associate is an associate with a high level of technical expertise and experience who acts as a resource for all associates. They independently perform basic to complex activities required for GMP manufacturing. They may assume a Lead associate role in the absence of a Lead operator. Responsibilities include operating and troubleshooting bioprocess manufacturing equipment, aseptic processing, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities. They must be technically proficient with a thorough to extensive theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a strong understanding of current GMP and safety standards and be able to apply this knowledge independently in a GMP manufacturing environment.
ESSENTIAL JOB FUNCTIONS:
- Prepare and process equipment and materials for manufacturing use including performing equipment functional checks, start up, basic maintenance and operation of single use bioreactors, purification columns and skids.
- Perform equipment function checks, preventative maintenance, standardization and calibration, and testing of in-process samples using analytical equipment following written procedures. Clean production cleanrooms and remove waste materials.
- With minimal to no supervision navigate and use with a thorough understanding manufacturing systems for process operation and process performance. They must be able to independently train junior associates on company policies, programs and procedures commensurate with their experience as a qualified trainer.
- Evaluates departmental documentation (e.g., Standard Operating Procedures, PBR’s), for GMP compliance, accuracy and completeness and author and revise as necessary. Reviews data, and trends.
- Participates in and provides input into the investigation of non- conformances in compliance with quality procedures, policies and regulations. Participate in innovation and continuous improvement activities.
- They must be able to make process decisions impacting GMP manufacturing including process performance independently with minimal to no supervision. They must be able to independently recognize, understand, assess, and resolve situations that require additional evaluation or analysis and report these events appropriately.
- They must be able to provide effective written or verbal communication to peers, associates, area management and to all manufacturing support groups.
- They must enforce the safe performance of activities and safely perform activities on the shift in order to prevent releases, accidents and injuries.
Education and Qualifications:
- Bachelor’s Degree in Life Sciences is preferred.
- 0-5 years’ industry related experience with a Bachelor’s Degree in Life Sciences
- 2-6 years industry related experience with a Associates Degree/certificate program
- 4-8 years industry related experience with a high school diploma
- Strong interpersonal and communications skills; written and oral.
- Solid understanding of applicable regulatory requirements.
While performing the duties of this job, the employee:
- Needs Ability to aseptically gown and/or sterile gown as needed
- Ability to work within environmental clean rooms
- Ability to function in a dynamic environment and balance multiple priorities simultaneously
- While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.