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QA Specialist - Systems


Job Description
QA Specialist – Systems
Job Title
QA Specialist I, II, or III
Job Status
Full Time
Depending on Business needs but likely to be 7:30 am to 5 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 one of the two following capacities 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 – Systems
Tasks associated with this role include, but not limited to, the following:

  Write APRs and manage events
· Audits Internal
· CC for SOPs, Forms, Specifications, and Procedures
· Audits External
· 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
· Manage/Type specs
· Issue AFA’s
· Create Lot Fields for MFG, PKG and forms used by QA
· Manage CAPA’s
· Assign & Track Events (CF, IR, INV, DEV, PDV, CAPA, CCR)
· Review of USP Changes
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.


Location - QA

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