Specialist, QA Engineering

Bristol Myers Squibb; New Jersey; On-site; USD 85,411 - 88,166; Full time

Benefits offered by this job

Comprehensive health coverage

401(k) plan available

Paid sick leave as required by law

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Assurance Specialist responsible for overseeing technology transfers and compliance within a collaborative manufacturing environment. This role requires at least six years of experience and a strong understanding of global cGMP and quality systems to ensure successful product introduction for clinical trials.

Qualifications

• Strong understanding of cGMP and quality systems required.
• Minimum six years of experience in the pharmaceutical industry essential.
• Knowledge of technology transfer processes necessary.

Responsibilities

• Lead QA activities for technology transfer.
• Ensure compliance with internal and regulatory standards.
• Coordinate with cross-functional teams.

Skills

Knowledge of technology transfer for manufacturing processes

Strong understanding of global cGMP and quality systems

Problem solving

Communication

Analytical thinking

Education

Minimum six years of experience in the pharmaceutical or related industry

Job description

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Direct message the job poster from Bristol Myers Squibb

This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Responsibilities :

• QA lead on technology transfer activities (process):
• Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
• Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
• Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
• Interact and collaborate with cross-functional teams to achieve common goals.
• Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
• Must be knowledgeable on change control process.
• Must be knowledgeable on the process and associated methods for the assigned product.
• Support Product/Program Lifecycle Management Activities
• Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
• Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
• Review media simulation activities to ensure successful execution and documentation.
• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of data.
• Create an environment of teamwork, open communication, and a sense of urgency
• Promote a mindset of continuous improvement, problem solving, and prevention
• Drive strong collaboration within the site and across the network
• Build trust and effective relationships with peers and stakeholders
• Drive improvements to remove inefficiencies, improve quality and optimize productivity.
• Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

Reporting Relationship:

• Reports to Senior Manager, QA Engineering

Qualifications:

• EDUCATION AND EXPERIENCE (As Applicable)
• Minimum of six years of experience in the pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.

Knowledge, Skills, and Abilities:

• Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
• Must have knowledge of technology transfer for manufacturing processes.
• Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.
• Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
• Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.
• Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Work is self-directed.
• Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
• Understands fundamental scientific problems.
• Must have strong quality background.

Working Conditions: (US Only)

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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 ($62-$64/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.

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 [e-mail].

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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