GMP Document Control Specialist

Bayport Laboratories

Houston (TX)

On-site

USD 45,000 - 65,000

Full time

10 days ago
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Benefits offered by this job

401(k)
Competitive salary
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Training & development
Vision insurance

Job summary

Bayport Laboratories is seeking a detail-oriented Document Control Clerk in Houston to support day-to-day management and archiving of quality records. You will prepare, file, issue, and track controlled documents, ensuring accuracy and compliance with GDP, FDA, and GMP standards.

Collaboration with Quality, Regulatory, Manufacturing, and other teams is essential for success. The role requires strong organizational skills, experience with EDMS, and proficiency in MS Word and Excel.

Qualifications

  • High school diploma or equivalent required.
  • Associate degree in Arts, Science, Applied Science, Business Administration, or related field preferred.
  • Experience in document control, records management, or regulated manufacturing preferred.
  • Cosmetics/pharmaceutical/regulated industries experience a plus.
  • Familiarity with GMP and GDP preferred.
  • Strong attention to detail and accuracy.
  • Proficient with Microsoft Word and Excel.

Responsibilities

  • Assist with preparation, filing, revision, and archiving of controlled documents.
  • Maintain document logs, trackers, and databases to ensure proper routing and approval.
  • Verify current and approved versions of documents and archive obsolete files.
  • Organize and maintain quality records for accuracy and accessibility.
  • Maintain electronic and hard-copy filing systems and retention per procedures.
  • Assist with document change requests, revisions, and approvals.
  • Enter and update information in EDMS and spreadsheets.
  • Support internal, customer, and regulatory audits and inspections.
  • Maintain employee training records related to procedures.
  • Distribute approved documents to departments and personnel.
  • Communicate document status and missing information across teams.
  • Maintain EDMS and ensure documents are organized and accessible.
  • Follow GDP, FDA, and GMP requirements for controlled documents.

Skills

Attention to detail
Organizational skills
Time management
Communication skills
MS Word
MS Excel
EDMS usage

Education

High school diploma or equivalent
Associate degree in related field

Tools

EDMS
MS Word
MS Excel
Outlook

Job description

Bayport Laboratories is seeking a detail-oriented Document Control Clerk in Houston to support day-to-day management and archiving of quality records. You will prepare, file, issue, and track controlled documents, ensuring accuracy and compliance with GDP, FDA, and GMP standards.

Collaboration with Quality, Regulatory, Manufacturing, and other teams is essential for success. The role requires strong organizational skills, experience with EDMS, and proficiency in MS Word and Excel.

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