Skip to content

Job Openings

Document Control Specialist - Quality Systems

San Diego, CA 92130

Posted: 02/05/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617537 Is job remote?: Hybrid Country: United States

Job Description

Job Description:
POSITION SUMMARY:

The Quality Systems Contractor is responsible for general support of the administration and maintenance of the document management and training programs. They support the Quality Management System (QMS) document and records archived at the San Diego/Minnesota facility. This individual will also perform a range of support activities within the Quality Systems group which include, but are not limited to: Complaint Handling, Records Administration, Quality Events, and audit support.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
  • Document Control Support
    • Facilitate timely processing of new documents, document changes and change controls.
    • Reviews internal documents prior to issuance to confirm compliance with company standards and works with document owners to resolve deficiencies.
    • Supports the periodic document review process to ensure timely completion of reviews.
  • Complaint Handling Support
    • Supports entry of product complaint reports into eQMS.
  • Training Program Support
    • Supports eQMS training program (MasterControl/Compliance Wire) to ensure training is deployed to appropriate personnel.
    • Provides supplemental support for the annual training plan review process.
  • Records Management Support
    • Supports QMS record storage, including organization and retrieval of records stored at the San Diego facility. Participates in the review of retained records for transfer to off-site storage locations or disposal as required.
    • Supports audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.
    • Provides input to support the continual improvement of document control, record management, and training administration processes.
    • Performs duties in accordance with the Company’s QMS and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
    • Maintains a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
    • Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • Minimum two years of college or work experience equivalent.
  • 3 or more years in medical device or pharmaceutical document management, change control management, and training administration systems.
  • An equivalent combination of experience and education may be considered.
  • Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Microsoft Word, PowerPoint, and Excel.
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.
  • Experience with eQMS software for document and record management and training administration. Knowledge of ComplianceWire and/or MasterControl a plus.
  • Customer Service oriented attitude and ability to exercise sound business judgment.
  • Proven ability to communicate effectively; orally and written.
  • Ability to prioritize workload to meet deadlines and to maintain high levels of quality and accuracy.
  • Able to work independently, as well as in a cross-functional team environment.
  • Ability to maintain confidentiality and discretion in business relationships.

ENVIRONMENTAL CONDITIONS:
Physical Activities:
On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.







Pay Rate Range: $30-45/hr depending on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About San Diego, CA

Ready to embark on an exciting career journey in sunny Southern California? Explore our job opportunities in the thriving city of San Diego! Known for its stunning beaches, perfect weather, and vibrant culture, San Diego offers a unique combination of career growth and quality of life. With renowned attractions like Balboa Park, the San Diego Zoo, and the USS Midway Museum, along with a diverse culinary scene and a plethora of art galleries and theaters like the La Jolla Playhouse, there's always something new to experience. Whether you're a sports enthusiast looking to cheer for the Padres at Petco Park or seeking outdoor adventures at Torrey Pines State Natural Reserve, San Diego has something for everyone. Begin your job search today and discover why this picturesque city is the perfect place to elevate your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.