Document Control Manager Santa Ana, CA | 6-9 Month Contract | $51-$60/Hour Are you a seasoned Document Control or Quality professional who enjoys leading teams, improving systems, and making a real impact in a regulated environment? Our client is looking for a Document Control Manager to take ownership of critical document control processes within a dynamic bioscience organization. This is a great opportunity to step into a leadership role where you'll work cross-functionally with Quality, Regulatory, Auditing, and Manufacturing teams while helping strengthen systems, streamline processes, and maintain compliance.
The Document Control Manager will:
Lead and support a team responsible for day-to-day Document Control activities. Oversee the creation, revision, approval, issuance, and maintenance of controlled documents, including SOPs, forms, posters, and product labels. Manage document control, training, and labeling systems to ensure information is accurate, current, and accessible. Own and improve the organization's electronic Quality Management System (eQMS), with MasterControl experience highly preferred. Oversee training documentation and comprehension verification. Manage manufacturing label control, including revisions, approvals, printing, and inventory. Coordinate product inserts, including translations, revisions, printing, and inventory management. Partner with internal teams and external suppliers to support labeling and document control needs. Identify opportunities to improve processes, increase efficiency, reduce costs, and strengthen Document Control programs. Support Regulatory Affairs with technical documentation for regulatory submissions. Partner with Quality Assurance during audits and provide documentation and technical support as needed. Help ensure Document Control activities remain aligned with applicable FDA, GMP, ISO, and global regulatory requirements.
Requirements:
Bachelor's degree required. 5+ years of experience in Quality Assurance and/or Document Control within a medical device, bioscience, pharmaceutical, or similarly regulated environment. 4+ years of supervisory or management experience preferred. Experience with eQMS systems; MasterControl strongly preferred. Solid understanding of FDA regulations, c
GMP, 21 CFR
Part 820, ISO 13485, and other applicable quality and regulatory standards. Strong Microsoft Office skills, particularly Excel. Experience with Adobe InDesign, Photoshop, or Illustrator is a plus. Excellent communication, organization, and problem-solving skills. Ability to manage multiple priorities in a fast-paced, highly regulated environment.
Pay:
$51.00 - $60.00 per hour
Benefits:
Dental insurance Health insurance Vision insurance