QA/QC Document Control Specialist

Job Description

Summary : The Document Control Specialist is responsible for the creation, management and maintenance of the GMP documents which includes but not limited to Standard Operating Procedures, test data sheets, controlled forms, deviation records and other GMP related documents.
Duties and Responsibilities:

  • Assists in training of plant personnel in SOPs and GMPs

  • Assists management in creating quality plans and procedures

  • Assists in the initiation, investigation and closure of product and process deviations/non-conformances

  • Recommends corrective actions for quality issues

  • Assists in preparation for customer audits and regulatory inspections

  • Reviews documentation to assure accuracy, completeness and errors

  • Performs reconciliation and closing of batch records

  • Submits documents to customers as requested (i.e. batch records, CoA, lab reports, etc.)

  • Ensures timely release of finished goods

  • Authors and revise SOPs and other related quality documents

  • Maintains and files quality records, reports, logs, etc.

  • Manages document processes and systems to ensure control and availability of documentation to site personnel

  • Coordinates the creation, revision, and distribution of controlled documents to plant management

  • Assigns control number to Document Change Requests

  • Conducts investigations concerning operational problems and/or problems involving customer complaints

  • Prepares complaint response for review and approval

  • Coordinates destruction of expired products and records

  • Prepares rework instructions for nonconforming products

  • Assists in validation/verification efforts

  • Assists in data mining and trending of quality issues

  • Assists in the monitoring and record keeping of pest control activities

  • Coordinates, schedules and maintains calibration of laboratory and manufacturing equipment

  • Performs other related duties as assigned by management

Work Experience/Qualifications:

  • Minimum of 2 years relevant work experience in document control management

  • Working knowledge of cGMPs and FDA regulations as it pertains to document control

  • Good interpersonal skills

  • Ability to work independently and in a team environment

  • Ability to read, write, and speak English

  • Ability to perform basic math

  • Ability to follow instructions

  • Good attendance and punctuality

  • Flexibility to changing priorities, work schedule, and the needs of the business

  • General proficiency in using Microsoft Word, Excel and Outlook

  • Ability to work well under pressure

  • Highly organized and detail oriented with ability to work effectively in a fast paced work environment

Education Requirements:

  • Minimum High School Diploma or equivalent

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