Major Duties And Responsibilities
- Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
- Liaise with multiple groups and organizations to ensure effective collaboration.
- Proactively manage the progression of investigations and CAPAs to achieve timely closure.
- Lead and participate in cross-functional investigation teams.
- Present investigation findings to key stakeholders and site management.
- Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
- Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results
Knowledge And Skills
- Required Bachelor?s degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2?4 years of relevant experience (or equivalent).
- Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
- Strong project management skills, including organization, collaboration, multi-tasking, and communication.
- Attention to detail and ability to perform well in a team-based environment.
- Excellent verbal and written communication skills, with the ability to present information clearly and concisely.
- Strong interpersonal and collaboration skills to influence all levels of the organization.
- Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred.
- Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
Contacts
- Work collaboratively with all departments and across all organizational levels.
Working Conditions
- Assignments primarily occur in the Large-Scale Cell Culture building, Single-Use Facility, and Quality Control Laboratory areas, requiring strict adherence to Personal Protective Equipment (PPE) standards. Site is located in Devens, Massachusetts.
Decision-Making
- Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges.
Supervision Received
- Assignments generally follow defined processes but may require judgment and independent detail definition. Supervisory guidance is provided as needed, with oversight determined by the complexity and impact of the task.
50% onsite required
Work Schedule: Mon- Fri (normal business hours)
This posting is for a contract assignment with
ASK Staffing DBA ASK Consulting to provide services to
Bristol Myer-Squibb.
The starting hourly compensation for this assignment is the following range ($50- $53.22/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer
ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.
California Applicant Notice
ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting HR@askconsulting.com.
Fair Chance Employment Notice
If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.
To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.
This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.
