QUALITY RECORDS SPECIALIST
SUMMIT, NJ

Hybrid - 50% remote 50% onsite.

Required Skills:

• Required minimum Associates of Science degree in relevant scientific discipline, OR 3 years' experience in biotherapeutics/biomanufacturing QC/QA.
• 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).

Project Description:

• The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL).
• Other duties may 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.
• 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.
• 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.
• May be required to work in office environment.
• Sitting, standing and computer work is required.
• Ability to participate in conference calls.

This 12+ month position starts ASAP.

ALPHA'S REQUIREMENT #23-00292
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Types: Full-time, Contract

Pay: $25.00 - $29.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Associate (Required)

Experience:

• biotherapeutics/biomanufacturing (QC/QA): 3 years (Required)
• deviation and change control management: 1 year (Preferred)
• Infinity systems: 1 year (Preferred)
• FDA/EMA regulations in the biotechnology industry.: 1 year (Preferred)

Work Location: Hybrid remote in Summit, NJ 07901

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