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Documentation Specialist
Ref No.: 18-07651
Location: San Diego, California
Role: Documentation Specialist
Location: San Diego, CA
Duration: 12 Months Contract
Pay Rate: $20-25/hr on W2

Job Description:
Have documentation system in place, but do not have individual to oversee it.
Someone with medical device manufacturing- not a must, but preferred
Travel required between SDDC, Freehold NJ, about 30%, mainly based in San Diego- more travel in the beginning of assignment to get acclimated, probably about one every two months, but about once a quarter after that

Doc control

Manager is selective and demanding, need someone who can meet those expectations

Goal is to convert, but for the right person. If candidate starts and is not working out, assignment will be ended

Under minimum supervision of the Director, this position is responsible for supporting the Quality Assurance and Regulatory Compliance Department with Document Control activities to ensure compliance to Quality System Regulations and standards such as; FDA regulations, ISO standards, Client's North America Distribution Center and Inverness Medical LLC Quality policies.

Duties and Responsibilities
  • Work in compliance with Client's North America Distribution Center Quality Management System and Quality Policy Requirements.
  • Support the department in implementing and maintaining a compliant Quality System per FDA and ISO requirements, throughout the Alere North America Distribution Center and Inverness Medical LLC.
  • Work in the Document Control System (DCS) shall include; writing of new Quality System documents, maintenance of existing documents, processing document change requests and coordinating the approval of SOPs, Work Instructions and Forms.
  • Provide Coordinator level support for the Agile PLM and Ensur DCS for both Client's North America Distribution Centers and Inverness Medical LLC site's as needed. Tasks include, but not limited to, progressing documents through the Agile PLM and Ensur workflow and provide support to workflow disturbances.
  • Provide support for the transition to / implementation of the Agile PLM system for Alere North America Distribution Center and Inverness Medical LLC.
  • Maintain the Document Change Order (DCO) process to support all sites under the Quality System.
  • Perform Document Control activities such as, but not limited to, document review and approval, data entry, filing, maintaining logs, processing documents, scanning documents, checking out and checking in documents and generating process trends.
  • As required, assign document identifiers to Quality and Manufacturing document types (e.g; SOP, WI, Validation studies) and provide assistance in creating such documents in ensur.
  • Assist Management with supporting functions relating to; equipment preventive maintenance logs, calibration files and forms.
  • Assist Management with supporting functions relating to the training program (data entry, filing training forms, creation of training files).
  • Analyze all sources of nonconformities and variances to identify trends and escalate to Quality Incident or CAPA system as appropriate.
  • Assist with CAPA and Quality Incident trending.
  • Support the supplier qualification process
  • Assist with internal audits and agency audits as required.
  • Support of site and BU management review.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Communicate the importance of the Quality Management System to all employees.
  • Other duties as assigned.

Minimum Qualifications
  • Must have strong organizational, interpersonal, written and verbal communication skills.
  • Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment.
  • Must be proficient in MS Outlook, Word, and Excel, data reporting, trending and analysis.
  • Proficiency in Agile PLM is a plus
  • Knowledge of Medical Device regulations and associated standards, e.g. QSR's, ISO 9001, ISO 13485 is a plus.
  • Must have reliable transportation.

Education & Experience
  • BA / BS (preferred) or High school diploma (required). Evidence of the pursuit of continued education in a field involving technical writing or strong documentation skills, including military experience, preferred.
  • 4-7 years of Document Control experience in a manufacturing or logistics environment, preferred.
  • Experience with an electronic document control management system
  • Experience with Agile PLM system, preferred.
  • Experience in a production / distribution, cGMP, type environment preferred.

This position is based in San Diego and may require up to 30% of travel.