Job Description
QA Specialist – Systems
Job Title
QA Specialist I, II, or III
Job Status
Full Time
Shifts:
Depending on Business needs but likely to be 7:30 am to 5 pm
Location
Fort Worth, TX
Reports To:
Quality Assurance Supervisor
Travel:
Little to None
Compensation:
Salary depending on experience
Relocation:
TBD
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 – Caution, Residual Solvent, EI, etc.
- Scanning and Archival of records, reports, procedures, etc..
- 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.
Job Type: Full-time
