Specialist, Shop Floor Quality Assurance

3 weeks ago

Devens, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Position Summary**

The Specialist, Field Quality Assurance Manufacturing, is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Functional responsibilities include triaging and supporting the resolution of unexpected events in conjunction with area owners; proactively monitoring process performance and identifying departures from accepted standards; conduct routine reviews and approvals of GxP documents including, but not limited to electronic batch record review, and logbooks; executing operational tasks in the electronic batch records such as, but not limited, to disposition of incoming apheresis patient material.

**The hours for this position are a rotating 6AM to 6PM Shift **.

**Key Responsibilities**
- Must be action-oriented and proficient with in decision-making, building relationships, problem-solving, and analytical thinking.
- Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Ability to assess an unfolding situation, diagnose the problem and propose practical solutions.
- Detail-oriented and task-focused with ability to meet deadlines and prioritize assigned work.
- Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
- Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
- Active listening skills to understand diverse working perspectives.
- Contributes to a positive team environment.
- Able to independently make decisions based on data and facts, and recognizes when to escalate
- Seeks opportunities for improvement to quality and operational problems.
- Ability to work within pharmaceutical cleanroom environments.
- Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
- Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
- Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

**Qualifications & Experience**
- Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered.
- 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
- Must be action-oriented and proficient with in decision-making, building relationships, problem-solving, and analytical thinking.
- Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Ability to assess an unfolding situation, diagnose the problem and propose practical solutions.
- Detail-oriented and task-focused with ability to meet deadlines and prioritize assigned work.
- Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
- Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
- Active listening skills to understand diverse working perspectives.
- Contributes to a positive team environment.
- Able to independently make decisions based on data and facts, and recognizes when to escalate
- Seeks opportunities for improvement to quality and operational problems.
- Ability to work within pharmaceutical cleanroom environments.
- Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
- Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
- Proficient w

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