Onsite Quality & Document Control Specialist (Contract)

Creative Solutions Services, LLC; Campbell (CA); On-site; USD 83,000 - 91,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

Job summary

Creative Solutions Services, LLC is seeking a document control professional to support the Quality Management System and regulatory compliance. You will manage document changes, train staff, and assist in audits while maintaining batch records and supplier documentation.

Ideal candidates have a technical writing ability, MS Office proficiency, and prior document control experience in a medical device environment. This is an on-site role in Campbell, CA with a 3-month assignment and daytime hours.

Qualifications

• Bachelor’s degree in related field and 1 year of work experience or an equivalent combination.
• Experience with quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001).
• Excellent written and verbal communication skills.
• Ability to review documents with thorough and meticulous attention to detail.
• Strong multi-tasking, organized work style and proficiency in MS Office.

Responsibilities

• Support the Quality Management System and regulatory compliance documentation.
• Identify gaps and revise forms, work instructions and procedures.
• Assist in investigations and CAPA activities with root-cause analysis.
• Provide support during audits and maintain quality metrics.
• Maintain approved supplier lists and track supplier qualifications.
• Review batch records and change orders for accuracy and completeness.
• Manage document control training planning and training administration.
• Promote the Quality Policy and ensure GMP/FDA compliance.

Skills

Detail oriented

MS Word

Excel

Cross-functional communication

Technical writing

Education

Bachelor’s degree in related field

Tools

Electronic QMS

Job description

Creative Solutions Services, LLC is seeking a document control professional to support the Quality Management System and regulatory compliance. You will manage document changes, train staff, and assist in audits while maintaining batch records and supplier documentation.

Ideal candidates have a technical writing ability, MS Office proficiency, and prior document control experience in a medical device environment. This is an on-site role in Campbell, CA with a 3-month assignment and daytime hours.