Bilingual Quality Assurance Document Control

Job Description

Job Description

A well-established pharmaceutical company in Miramar, FL is seeking an experienced and detail-oriented Quality Assurance (QA) Document Control Specialist to support its evening shift operations. This role is responsible for maintaining, reviewing, and managing GMP documentation to ensure compliance with regulatory standards. The ideal candidate is bilingual (English/Spanish), organized, and has prior experience in pharmaceutical or FDA-regulated environments.

Location: Miramar, FL
Industry: Pharmaceutical Manufacturing
Job Type: Full-Time
Schedule: Monday to Friday, 2:30 PM – 11:00 PM
Pay: $19.00 per hour

Key Responsibilities

• Maintain and control quality documentation in accordance with GMP and FDA guidelines

• Review and archive manufacturing, packaging, and testing records for accuracy and completeness

• Ensure proper version control and distribution of controlled documents (SOPs, batch records, etc.)

• Assist in audits, inspections, and internal reviews by preparing and providing requested documentation

• Support QA team in implementing document changes, updates, and approvals

• Ensure timely and accurate entry of documentation into digital or physical filing systems

• Collaborate with production, quality, and regulatory departments to ensure documentation compliance

• Report any deviations or non-conformances found in records

Qualifications

• Minimum 1–2 years of experience in document control or QA in a pharmaceutical or FDA-regulated environment

• High school diploma or equivalent required; associate or bachelor's degree preferred

• Strong knowledge of GMP, SOPs, and document control best practices

• Excellent attention to detail and organizational skills

• Bilingual (English/Spanish) – required

• Proficient in Microsoft Office (Excel, Word, Outlook)

• Ability to work independently with minimal supervision during evening shift hours