Associate Document Specialist - 1st Shift

Prestige Consumer Healthcare; Lynchburg (VA); On-site; USD 25,000 - 29,000; Full time

Job summary

Fleet Laboratories is seeking an Associate Document Specialist – 1st Shift in the Quality Assurance department. You will issue and manage controlled documents, support training records, and ensure compliance with GMP regulations in a fast-paced lab environment.

The role requires a high school diploma plus technical QA education and at least two years of related work experience. On-site position with standard daytime hours.

Qualifications

• High school diploma and one year of technical education in quality assurance or other related discipline.
• Two years of related work experience.

Responsibilities

• Issues controlled documents including procedures, batch records, analysis reports, logbooks, and laboratory notebooks.
• Monitors the document control system, policies, procedures, and work instructions.
• Assists with implementation, configuration and validation of the document control database.
• Performs duties in a cGMP (21 CFR Parts 11, 210 & 211) environment to ensure compliance with Good Documentation Practices.

Skills

Document control

GxP compliance

Education

High school diploma

Technical education in QA

Job description

Associate Document Specialist – 1st Shift

DEPARTMENT: Quality Assurance

For over 150 years, Fleet Laboratories’ success has come from adapting to a changing world with creative thinking and innovative product development. We've grown into a global leader of over 100 personal health and beauty products. As the world keeps evolving, so will we, with unique new technologies and products that help our customer’s look and feel your best.

OCCUPATIONAL SUMMARY

Perform the various functions of Document Control: Issues controlled documents including procedures, batch records, analysis reports, logbooks, and laboratory notebooks; reviews all controlled documents submitted for approval via the document control / change control system; and maintains corporate records in accordance with retention schedules and procedures. Supports learning management by participating in training and supporting training record keeping.

ACCOUNTABILITIES

• Issue controlled documents including procedures, batch records, analysis reports, logbooks, and laboratory notebooks.
• Perform monitoring of the document control system, policies, procedures, and work instructions.
• Assist with implementation, configuration and validation of database, as directed.
• Perform the various functions of Document Control in a cGMP (21 CFR – Parts 11, 210 & 211) environment to ensure compliance with Good Documentation Practices and appropriate regulations.
• Performance of duties increases customer goodwill, prevents costs associated with product failures, and prevents costs associated with possible regulatory non-compliance issues.

RESPONSIBILITIES

• Issues controlled documents including batch records, analysis reports, logbooks, laboratory notebooks, etc., in a timely manner per schedule.
• Provides controlled document copies to points of usage.
• Files product batch records, logbooks, and laboratory notebooks for record retention.
• Assists with corporate record retention activities, including staging records, providing record labels to record owners, ensuring record logs are complete, current and accurate, and moving records into identified locations.
• Ensures all documentation supporting document creation and document change control is complete and appropriate as submitted. Supports document collaboration with authors and owners to identify necessary corrections.
• Support a variety of Quality functions such as drafting Document Control procedures, assisting in the training of employees regarding the use of the document control application, auditing records and work area, and providing requested documents / records, as directed.
• Assist with report preparation and other clerical duties associated with the Document Control area, and maintain work area/equipment in a safe, clean, and organized condition.
• Assist with implementation, configuration and validation of document control system, as directed.
• Perform other duties as needed.

QUALIFICATIONS

• High school diploma and one year of technical education in quality assurance or other related discipline or the equivalent.
• Two years of related work experience

ACCOUNTABILITY: Manager, Quality Applications

Compensation Range: $18.00 - $21.36 hourly

No Sponsorship

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.