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QA - Document Control (Manufacturing & Production)
Fort Worth, TX 76118
Recruited by: Nydia Villegas | Recruiter | Sovereign Pharmaceuticals LLC See all my Jobs

  • Hiring Company: Sovereign Pharmaceuticals, LLC
  • Industry: Manufacturing & Production
  • Compensation: to be determined
  • Expires: Dec 19, 2020
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Job Description

QA  - Document Control

Job Title
QA Specialist - Document Control

Job Status
Full Time

Monday through Friday 8:00 am to 4:30 pm 

Fort Worth, TX

Reports To:
Quality Assurance Supervisor

Little to None

Salary depending on experience

Seeking a motivated individual(s) to fill a QA Specialist role we have available in the following capacity based on the candidate’s sills. With a high level of confidence, detail oriented, and organization skill set to complete tasks and provides solutions with ever changing priorities.
QA Specialist – Document Control
Tasks associated with this role include, but not limited to, the following:

• Document archival
• Review of USP Changes

• CC for SOPs, Forms, Specifications, and Procedures
• Manage/Type specs

• Customer notifications (CCs)
• GMP Training

• FDA application documentation
• Pest Control

• Filed Product Annual Report Documentation
• AQR Building Temp-Humidity Review

• Manage master documents (paper and electronic scans)
• Annual Product Review,

• Prepare documents for scanning (batch records, reports, procedures)
• Product Reports – Cation, Residual Solvent, EI, ect.

• Scanning and Archival of records, reports, procedures, ect.
• Product regulatory information

• Customer Notifications of events (CCRs, INV & DEV)
• Annual Starting Material Review

• Write SOP’s/forms
• Annual Quality Summary Report

• Create Lot Fields for MFG, PKG and forms used by QA
• Issue AFA’s

• Assign & Track Events (CF, IR, INV, DEV, PDV, CAPA, CCR)
• Manage CAPA’s
The ideal candidate will possess:
• Good organizational skills
• Must be detailed oriented while managing multiple priorities.
• Ability to prioritize work, to meet deadlines and to work under stressful conditions.
• Ability to work well with others
• Ability to communicate effectively in English, both written and verbal
• Ability to work independently
• Strong technical writing skills and problem solving
• Strong computer skills with knowledge of Word, Word Styles, building Excel Tables, Charts & Pivot Tables
Basic Minimum Qualifications:
• Minimum of high school diploma or equivalent, a 4 year college degree is preferred for the more technical aspects.
• Preferred minimum 3 years of pharmaceutical experience, but not required.