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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.

QA Associate Specialist – Document Control

Job Description

  • Type: Contract
  • Job #72353

Our client, a leading pharmaceutical company, is hiring a QA Associate Specialist – Document Control on a contract basis.

Work Location

Bothell, WA

Summary

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education: Bachelors degree or equivalent

Experience Basic Qualifications:

• Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment

• Strong communication and customer service skills.

• Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement

• Able to prioritize, manage time well, multi-task, and troubleshoot effectively

• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables

• Possess project management skills.

• Experience interacting with FDA or other regulatory agencies strongly preferred

• Strong knowledge of cGMPs and domestic regulatory requirements

• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)

• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network

• Some labeling experience strongly preferred

 

DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:

• Issuing production batch records, labels, and other controlled documents to support manufacturing operations

• Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.

• Assist with managing the Document Center Archive room

• Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective state

• May write and revise document control procedures including participating in the development and roll-out of document control tools

• Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests

• Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures

• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site

• Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections

• Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data

• Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders

 

 

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