To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepakarya8a79aa22a/), email your updated resume at Email deepak.arya@collabera.com. Thank you!

Pay Range: $35 to $45 an hour.

Job Summary:
We are seeking a highly organized and detail oriented Document Control Specialist to support quality documentation and change control activities within a regulated pharmaceutical or medical device environment. The role is responsible for processing, reviewing, maintaining, and routing controlled documents through electronic document management systems while ensuring compliance with GMP and regulatory standards. This position partners closely with quality, regulatory, manufacturing, and operations teams to maintain documentation accuracy and workflow efficiency. The ideal candidate will have experience supporting document lifecycle activities, controlled documentation practices, and change management processes within a quality driven environment.

Key Responsibilities:

• Process, review, edit, and route controlled documents within the electronic document management system.
• Maintain procedures, specifications, forms, test methods, and other quality system documentation.
• Coordinate document reviews and approvals with cross functional teams to ensure timely completion.
• Support document lifecycle management including version control, updates, archival, and compliance tracking.
• Review and evaluate low impact changes within the electronic change management system.
• Ensure documentation complies with GMP standards and internal quality procedures.
• Support quality teams during audits, inspections, and documentation reviews.
• Track document workflows and maintain accurate quality records within the system.

Required Qualifications:

• Bachelor’s degree with 3 years of experience in document control or change control or Associate degree with 5 years of relevant experience.
• Experience working within pharmaceutical or medical device environments.
• Hands on experience with electronic document management systems.
• Knowledge of GMP regulations and quality systems.
• Experience with Veeva, TrackWise, or similar quality management platforms.
• Strong MS Office skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities independently.

Preferred Qualifications:

• Experience supporting change management workflows.
• Prior experience working with electronic quality management systems.
• Experience supporting audits and regulatory inspections.
• Familiarity with controlled documentation processes in regulated environments.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, longterm disability insurance, shortterm disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)