ECLARO
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
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
#J-18808-Ljbffr
$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
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
#J-18808-Ljbffr