Quality Assurance Specialist

3 days ago

Summit, New Jersey, United States System One Full time
Job Title:

Quality Records Specialist

Location:

Summit, NJ

Hours/Schedule:

Monday to Friday, Business Hours

Type:

Contract

Overview:

A leading pharmaceutical company is seeking an experienced Quality Records Specialist to join their team. The ideal candidate will have a strong background in deviation and change control management, preferably with Infinity systems.

Responsibilities:
  1. Initiate, facilitate, and track quality records
  2. Provide regular communication and metrics for the status of quality records
  3. Effectively communicate issues, risks, and proposed solutions within the organization
  4. Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
Other Duties:
  1. Create and revise Standard Operating Procedures (SOPs)
  2. Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
  3. Enter data and retrieve information from SharePoint and Smartsheet testing trackers
Requirements:
  1. Experience with deviation and change control management, preferably with Infinity systems
  2. Strong organizational skills, including the ability to follow assignments through to completion
  3. Ability to work in a fast-paced environment, meet deadlines, and prioritize work from multiple projects
  4. Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams
  5. Detail-oriented with demonstrated application in problem-solving
  6. With moderate oversight from manager, think strategically and understand global impact of decisions
  7. Advanced project management skills, such as process excellence/six sigma methods and approaches, including process mapping, root cause analysis, and problem definition
  8. Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.
  9. Experience with Clinical and/or Commercial products manufacture, supply, and post-approval change management
  10. Knowledge of applicable FDA/EMA regulations in the biotechnology industry
  11. Experience managing external suppliers and other supply chain issues
  12. Experience with Quality Systems (change control, deviation, and investigation)
Preferred Qualifications:
  1. Preferred Bachelor's degree in a relevant scientific discipline, or 3 years' experience in biotherapeutics/biomanufacturing QC/QA
Benefits:

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries, including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America.

We help clients get work done more efficiently and economically, without compromising quality.

System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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