Documentation Specialist (Change Control) (Pharma/Medical Device)

100% onsite.

• Will be creating Inspection plans within the Receiving Inspection team by converting paper documents to electronic.
• Must have MS Office Skills.
• Able to navigate multiple electronic platforms. Tech writing skills are a must. Windchill exp a plus but not required-will be trained.
• Manager would like to see Associate's degree or higher but not required.
• Any degree will suffice. Med device exp desired but not required.

Job Summary:

The Coordinator II, Document Control position is responsible for effective change request administration, properly applied configuration control concepts, providing technical support to project teams as required, maintenance of controlled documentation and records, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures.

Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.

Assure Effective Change Order Administration:

• Ensure that all change requests comply with procedure requirements.
• Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.
• Coordinate implementation of change requests with all affected areas/facilities.
• Prioritize and schedule completion of approved change orders.
• Work with remote facilities as necessary to assist in changes that affect multiple locations.
• Maintain appropriate logs and records.
• Provide assistance to change requestors in updating documents, creating or updating Bills of Materials and submitting change requests etc.

Maintain accurate configuration control:

• Control part numbers and revision level assignments.
• Maintain product configurations by ensuring accuracy of Bills of Materials.
• Control Device Master Records.
• Maintain item master accuracy by updating additions, deletions, and other changes as required.

Assure effective documentation control administration:

• Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.
• Distribute notifications and updated documents to applicable areas, as required.
• Proofread documents for accuracy and adherence to policies, as necessary.

Provide technical support to Engineering projects:

• Support Engineering projects to ensure accurate product configuration and documentation of new products.
• Support project teams to ensure change requests are implemented to meet deadlines.
• Support Custom Device Requests to ensure accurate documentation, as necessary.

Miscellaneous:

• Create change orders for personnel as requested.
• Provide support to archiving activities.
• Support Customer requests such as; retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists etc.
• Evaluate activities and identify areas of improvement and carry out improvement activities
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Equipment: List the type of equipment the incumbent will utilize in this position.

• May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
• Working Conditions: Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job. Working environment varies from standard office/cubicle with air/sound/light control to general laboratory and production areas with varying physical conditions including “clean room” situations.

General Qualifications

• High School degree or equivalent.
• Solid computer skills and report writing skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Job Type: Contract

Pay: $25.00 - $27.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• processing of all documentation change requests,: 2 years (Preferred)
• Pharma or medical device industry: 2 years (Preferred)
• Document management systems: 2 years (Preferred)

Ability to Commute:

• San Ramon, CA 94582 (Required)

Work Location: In person

Salary : $25 - $27