Quality Records Specialist

About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Full Time/ 1 year + with a possibility of extension
Job Location: Summit, NJ
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $30 per hour.
1st shift
Individual selected will process external deviation and change records from our client’s contract test laboratories (CTL). Other duties include coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.
Responsibilities:

• Initiation, facilitation, and tracking of Quality Records.
• Provide regular communication and metrics for status of Quality Records.
• Effectively communicate issues, risks and proposed solutions within the organization.
• Provide communication, support, and guidance to CTLs within the QA vector and upstream material team.

Other duties may include:

• Working closely with other GSQ QC members to submit and track sample material for testing at CTL.
• Create and revise SOP.
• Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
• Enter data and retrieve information from SharePoint and Smartsheet testing trackers
  

Qualifications:

• Bachelor’s degree in relevant scientific discipline, prefer 3 yeas’ experience in biotherapeutics/biomanufacturing QC/QA or an equivalent combination of education and experience.
• Experience with deviation and change control management, preferably with Infinity systems.
• Strong organizational skills, including ability to follow assignments through to completion.
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work from multiple projects.
• Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams.
• Detail oriented with demonstrated application in problem solving.
• With moderate oversight from manager, think strategically and understand global impact of decisions.
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
• Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.
• Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management.
• Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
• Experience managing external suppliers and other supply chain issues.
• Experience with Quality Systems (change control, deviation and investigation)

Apply Today!
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.
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