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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Quality Records Specialist

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #73137

Our client, a leading pharmaceutical company, is hiring a Quality Records Specialist on a contract basis.

Work Location

Summit, NJ/Hybrid

Summary

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.

 

DUTIES AND 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

 

REQUIRED COMPETENCIES:

• 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

 

DESIRED COMPETENCIES:

• 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)

 

Education and Experience:

 

Associates of Science degree in relevant scientific discipline, or 3 years experience in biotherapeutics/biomanufacturing QC/QA, or an equivalent combination of education and experience.

 

 

 

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