Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.
Duties/Responsibilities
- Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples.
- Perform review of testing data (e.g., data packets, final lot file, COA review).
- Anticipate and perform complex troubleshooting and problem solving independently.
- Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
- Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- May represent the department in regulatory inspections (internal and external audits).
- Train and mentor others on multiple QC test methods, processes and procedures.
- Cross trained on multiple complex analytical methods and/or multiple products.
- Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
- Perform other tasks as assigned.
Qualifications-Specific Knowledge, Skills, Abilities
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
Education/Experience/ Licenses/Certifications
- Bachelor?s degree or equivalent required, preferably in science. Advanced degree preferred.
- 4 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
Reporting Relationship
- This position will report to QC management.
100% onsite
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 ($40- $44.63/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 contactingHR@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 andCCPA 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.
