layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA at Bristol Myers Squibb

Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
Ensure the corrective/ preventive actions are robust and adequately address the root cause
May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions. Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions.
Knowledge, Skills, Abilities: Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
Ability to work in a fast-paced team environment and changing priorities.
Detail oriented and task focused with ability to meet deadlines and support work prioritization.
Able to work across functional groups and teams to ensure requirements are met.
Self-motivated and contribute to a positive team environment.
Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
Curious and ability to think critically to create innovative solutions.
Minimum Requirements: Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
4+ years of experience in a regulated industry with 1+ year deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with electronic system and databases
Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1605463 : Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA

Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA

Employer job description

Responsibilities:

Compensation Overview:

Benefits:

About this listing