Senior Specialist, Field Quality QA Operations Devens - MA - US R1603371
$89.53k - $108.49kBristol-Myers Squibb
- # Senior Specialist, Field Quality QA OperationsDevens - MA - USFind out how well you match with this job**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. 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. Read more: careers.bms.com/working-with-us.Summary:This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use.The role also working closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations, and conducting proactive area inspections and readiness reviews to uphold both internal quality standards and external regulatory requirements.This is a high-visibility, floor-based role that is integral to real-time quality assurance, batch release readiness, and audit preparedness. The absence of this resource creates increased risk for delayed batch review, reduced on-floor QA presence, gaps in RTS activities, and decreased support in deviation resolution.Shift Available: Monday - Friday, Onsite Afternoon Shift (2 p.m. - 10:30 p.m.) Responsibilities: * Quality floor support of complex manufacturing activities* Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.* Perform walkthroughs of GMP areas documenting observations and areas of concern.* Perform training on routine facility Quality tasks for new team members.* 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.Knowledge & Skill: * Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.* Knowledge of US and EU cGMP regulations and guidance.* 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.* Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff, as they conduct record reviews and respond to events occurring during day to day operations.* Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Coordinates with higher level leads and/or supervisor on decisions and applies appropriate notification to management as appropriate.* Receives assignments which require the application of a defined process to complete the assignment. As such specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.Basic Requirements: * Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is preferred.* 4 years of Quality Assurance experience within the pharmaceutical or medical device industry.* Batch record review experience.Working Conditions:* Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals.* Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment.*If you come across a role that intrigues you but doesn’t 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.*******Compensation Overview:******Devens - MA - US: $89,530 - $108,490 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.**Work-life benefits include:**Paid Time Off* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility\*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.***\*Eligibility Disclosure:** *T*he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.***Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through scienceTM ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.**On-site Protocol**BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.**Supporting People with Disabilities**BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1603371 : Senior Specialist, Field Quality QA Operations
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 2 days ago
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