Specialist, Quality Assurance Operations - Devens, MA
Specialist, Quality Assurance Operations - Devens, MA
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.
Position: Specialist Quality Assurance Operations
Location: Devens MA
******* Shift Mon-Fri 10:30 am to 7:00 pm ******
Key Responsibilities:
Quality floor support for minor and routine manufacturing activities
Performs routine manufacturing batch production record review for media/buffer/cryo in support of product release in accordance with specifications and SOPs.
Perform walkthroughs of GMP areas documenting observations and areas of concern.
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
Assures all electronic and paper documentation which requires QA review is in compliance with corporate and site procedures cGMP regulations and other industry guidelines.
May support the Quality review of manufacturing deviations.
May support release of incoming or manufactured products
Routine QA Floor Support Activities including but not limited to alarm review logbook review etc.
Other duties as assigned
Additional Qualifications/Responsibilities
Qualifications & Experience:
Knowledge of science generally attained through studies resulting in a B.S. in science engineering biochemistry or related discipline or its equivalent is preferred.
A combination of 2 years relevant experience in a regulated environment or mix of Co-Op and regulated environment is preferred
Knowledge of biotech bulk and finished product manufacturing analytical testing is desirable.
Familiarity with US and EU cGMP regulations and guidance.
Working knowledge of common computer systems such as MS-Word and Excel is required.
Knowledge of electronic or paper batch record systems DeltaV and other electronic systems applicable to laboratory test result generation inventory management investigations and equipment tracking and maintenance is desirable.
If you come across a role that intrigues you but does not perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
The starting compensation for this job is a range from 81800 - 99100 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Unclear Seniority
Employment Type
Full Time
