Ocok Document Control Specialist Jobs

Manage vendor documentation (Vendor Qualification Reports, CoAs, SDS).

Manage the approval and archival of SOP, WI, Process Flows, CAPA, OOS, deviations, nonconformance, complaints and investigation as required.

Support validation and qualification of process equipment, lab equipment, stability chambers, cleaning, and utilities.

Manage New Equipment Asset lists and assign numbers for all new equipment added to the facility.

Five years’ experience in GMP environment with relevant Quality Assurance/Compliance experience

Knowledge of FDA 210, 211 and ISO 13485, 9001, 22716 preferred

• Assist management on departmental projects, as necessary

Rate: Open based on Experience

• Strong knowledge of Microsoft Office Suite and Adobe Acrobat

• Good verbal and written communication skills

• Strong organizational skills; must be detailed-oriented

Job Title: Document Control coordinator

JOB KNOWLEDGE, SKILLS, AND ABILITIES:

Manage the Document Control change processes for ECO, MCO, Deviations and Stop Notices

Other duties and responsibilities as assigned.

2 years of experience using PLM, ERP or MRP tools for electronics manufacturing.

Experience with Arena Solutions Empower preferred.

Skilled in Microsoft Word, Excel, and Adobe Acrobat.

Assists OCOK management staff with data entry as assigned/required.

Attends relevant in-service training offered at ACH and/or OCOK to expand knowledge of the position.

Ensures contract outcome measures are met with emphasis on the data entry and collection of information.

Refrains from assuming any duty that is unrelated to and/or interferes with the responsibilities of the position.

Continues to work to improve skills needed for position held.

Participates in meetings as required/assigned.