QA Associate Specialist - Document Control

ECLARO; Lawrence Township (NJ); On-site; USD 42,705 - 45,460; Full time

Benefits offered by this job

401k Retirement Savings Plan

Commuter Check Pretax Commuter Benefits

Medical, Dental & Vision Insurance

Job summary

A leading healthcare solutions provider in Lawrence Township, NJ is seeking a QA Associate Specialist - Document Control. The role involves managing and maintaining controlled documents to ensure compliance with regulatory standards. Applicants should hold a Bachelor's degree and have 2+ years of relevant experience in a regulated environment. Benefits include a 401k plan and eligibility for various insurances.

Qualifications

• 2+ years of experience in document control, quality assurance, or regulatory affairs.
• Knowledge of regulatory requirements for documentation in life sciences.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Administer document control system ensuring accuracy and compliance.
• Support internal and external audits by providing documentation.
• Monitor document lifecycle and ensure timely review and revision.

Skills

Attention to detail

Organizational skills

MS Word proficiency

Written communication skills

Verbal communication skills

Education

Bachelor’s degree in Life Sciences or related field

Tools

Document management systems (Veeva, MasterControl, SharePoint)

Job description

QA Associate Specialist - Document Control

Base pay range

$31.00/hr - $33.00/hr

Job Number: 25-05077

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QA Associate Specialist - Document Control for our client in Lawrence Township, NJ.

ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview

• The Document Control Specialist is responsible for managing, organizing, and maintaining controlled documents, including Standard Operating Procedures (SOPs), work instructions, policies, and records, to ensure compliance with regulatory requirements and company standards.
• This role supports the creation, review, revision, distribution, and archiving of documents within a regulated environment.

Pay Rate: $31.00-$33.00/Hour

Responsibilities

• Administer the document control system, ensuring accurate tracking, version control, and distribution of controlled documents.
• Review, format, and process documents such as SOPs, policies, protocols, and reports for compliance with company standards and regulatory requirements.
• Coordinate document review and approval workflows, ensuring timely completion and proper authorization.
• Support internal and external audits by providing requested documentation and ensuring records are audit-ready.
• Monitor document lifecycle, including periodic review, revision, and obsolescence.
• Ensure compliance with industry regulations (e.g., FDA, EMA, ICH-GCP) and company policies.
• Assist in the development and improvement of document control processes and systems.
• Respond to document-related inquiries from internal teams and external partners.

Required Qualifications

• Education: Bachelor’s degree in Life Sciences, Business Administration, or related field (or equivalent experience).
• 2+ years of experience in document control, quality assurance, or regulatory affairs, preferably in a pharmaceutical, biotech, or medical device environment.
• Advanced proficiency with MS Word.
• Familiarity with document management systems (e.g., Veeva, MasterControl, SharePoint).
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced, regulated environment.
• Knowledge of regulatory requirements for documentation in the life sciences industry.

Preferred Qualifications

• Experience supporting FDA or other regulatory inspections.
• Certification in document control or quality management (e.g., ISO, ASQ).
• Advanced proficiency with electronic document management systems.

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

If interested, you may contact:

Paul Quibuyen

[e-mail]

6466952942

Paul Quibuyen | LinkedIn