Specialist, QA Shop Floor - Summit, NJ
Specialist, QA Shop Floor - Summit, NJ
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$ 72640 - 88000
1 Vacancy
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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.
The QA Shop Floor Specialist is responsible for quality oversight of Manufacturing Operations in accordance with Bristol-Myers Squibb policies standards procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures providing real-time review of manufacturing records and logbooks and working with Manufacturing Operations to resolve issues.
Shift(s) Available:
Sunday - Wednesday (with e/o Wednesday off) Onsite Day Shift 5 a.m. to 5:30 p.m.
Responsibilities:
Build and maintain relationships with Manufacturing Operations Quality Control Manufacturing Science & Technology and other departments to effectively complete tasks improve processes and resolve issues.
Ensure manufacturing compliance with applicable procedures and batch records.
Identify non-conformances to validated processes and procedures. As needed conduct cross-functional meetings with Subject Matter Experts (SMEs).
Conduct routine walkthroughs of GMP areas and communicate findings to area owners and Quality Management.
Review by exception for electronic manufacturing batch records.
Issue production batch records and product labels to Operations.
Support quality initiatives to drive continuous improvement and foster a quality-driven culture.
Additional Qualifications/Responsibilities
Knowledge & Skills:
Must have strong authorship and ability to critically review investigations interpret results and generate technical conclusions consistent with Quality Risk Management principles.
Must be skilled in planning and organizing decision-making and building relationships.
Knowledgeable of quality processes including material disposition change control product complaints deviations investigations and CAPA management.
Must be able to work in a cleanroom environment for up to 6-hour intervals.
Must be available for weekend and off-shift hours.
Must be flexible for shift hour changes to support manufacturing.
Must have sound knowledge and experience in FDA-regulated cGMP manufacturing operations and processes.
Must be action-oriented and customer-focused and skilled in decision-making building relationships problem-solving conflict management planning and organizing resource allocation coaching others and analytical thinking.
Must possess an independent mindset.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Confident in making decisions for non-routine issues.
Routinely recognizes and resolves quality issues.
Proposes solutions for complex issues and works with management to resolve them. Follows established procedures and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Must be action-oriented and customer-focused and skilled in decision-making building relationships problem-solving conflict management planning and organizing resource allocation coaching others and analytical thinking.
Understands continuous improvement and improves efficiency and productivity within the group or project.
Builds relationships internally within and with cross-functional teams.
Contributes to organizational and department goals.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Able to effectively multi-task.
Knowledge of US and global cGMP requirements.
Excellent verbal and written communication skills.
Basic Requirements:
Bachelors degree. An equivalent combination of education and experience may be considered.
3 years of cGMP work experience.
1 prior year of deviation/deviation mgmt. experience.
1 year of familiarity with all the following: Oracle SAP EBR and QMS.
The starting compensation for this job is a range from $72640 to $88000 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
