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Job Opening: Document Control Specialist

Document Control Specialist (Expired)

Fremont, CA

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Description

The Document Control Specialist is responsible for ensuring all customer/regulatory documentation is free from errors and maintained as specified by all applicable regulations. This role focuses on developing and maintaining efficient record-keeping systems that enable fast and easy access to important information. The records, policies, and procedures developed must cover the handling of data across its life span, from creation to storage, retrieval, and destruction. Precision and accuracy are required when inputting data and filing it correctly. The position also requires monitoring compliance with data privacy laws, training end users in record management software, and providing technical support. Document Management: • Operate within the quality manual, procedures, and work instructions of MASS Precision. • Adhere to Good Documentation Practice (GDP) and ensure documentation does adhere to cGMP regulatory standards. • Oversee and organize the routing of documents through the processes of conceptualization, approvals, distribution, and retention in MASS Precisions network. • Proficient interpretation of customer prints and specifications, ensuring compliance in organization and documentation. • Review and initiate Engineering Change Orders (ECOs) to ensure they meet organizational standards. • Identify gaps and propose process improvements based on organizational and regulatory standards. Record Management & Support: • Display strong blueprint reading skills with a comprehensive understanding of GD&T, tolerancing, and specification comprehension. • Generate, review, and retain documentation such as Bubble Drawings, First Article Inspection Reports, and Device History Records. • Review completed document packages for accuracy, collaborating cross-functionally to address issues. • Attending company production meetings, representing the document control department. • Generate and provide certificates (e.g., Certificate of Conformance, REACH Certificates)

Technical Proficiency:

  • Ability to multitask and complete assignments in a timely manner with accuracy.
  • Proficient in interpreting engineering drawings and advanced blueprint interpretation.
  • Experience with Net-Inspect, DISCUS, SolidWorks Inspection preferred. Familiarity with other DC software such as Discus and Net-Inspect is an advantage.
  • Epicor experience is preferred, with the ability to manage DC dashboards in MASS Precisions ERP system.
  • Proficient with MS Office, including Word, Excel, and PowerPoint. Advanced skills in MS Word, Excel, and PowerPoint, such as formulas, templates, tables, styles, headers, and cross-referencing, are beneficial.

Regulatory & Standards Knowledge:

  • Working knowledge of ISO 9001 and ISO 13485 requirements.
  • Familiarity with cGMP regulatory issues, industry publications, standards, and guidance.
  • Adherence to Good Documentation Practice (GDP) and understanding of its importance in maintaining quality standards.

Communication & Interpersonal Skills:

  • Excellent written and verbal communication skills, with the ability to communicate effectively across the organization.
  • Ability to work effectively as part of a cross-functional team, collaborating with various departments to ensure documentation accuracy and compliance.
  • Ability to follow verbal instructions and provide guidance to other team members when needed.

Operational Skills:

  • Detail-oriented with a focus on precision and accuracy in all tasks.
  • Ability to type at least 40 words per minute.
  • Ability to commit to a flexible schedule and ensure punctual arrival for scheduled shifts.
  • Ability to be cross-trained in other departments to assist during high-demand periods.

Physical Requirements & Safety:

  • Required to lift and carry up to 25 lbs.
  • Required to wear PPE when in the production area to ensure safety.
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