QA Associate

• Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
• Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
• Inspects and releases intermediates or packaged drug product per specifications.
• Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
• Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
• Provides site wide support during daily walkthroughs of GMP areas.
  
  

Top Skills

• Documentation Review experience
• Scientific Degree
• Experience working in a GMP environment
• Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.
  
  

Requirements

• B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
• 2 years of relevant experience in a regulated environment with at least 2 years focused on quality assurance function.
• Knowledge of pharmaceutical or biotech product manufacturing.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of SAP or equivalent ERP System, , BMRAM, MES, Veeva or Track Wise systems are a plus
• Role may entail use of disinfection agents (such as IPA or Sporklenz), Gowning/ PPE requirements to enter clean room spaces and handling of blood-based drug products.
  
  

100% onsite

Work Schedule:Wednesday - Saturday, 6AM - 4:30PM PST* (Shift: 4 x 10h shift)

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 ($31- $34.22/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 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.