QA Specialist - Review & Release

QA

QA Specialist

Job Title

QA Specialist I, II, or III

Job Status

Full Time

Shifts:

Depending on Business needs but likely to be 2:00 pm to 10:30 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 – Review / Release

Tasks associated with this role include, but not limited to, the following:

· Technical review of Laboratory Data, specifically electronic date review in Empower.

· Review/Disposition executed MFG/PKG Records

· Disposition Laboratory Data

· Physically tag blend, bulk product, finished product & raw mats

· Disposition Raw Materials

· Finalize all documentation for product release

· Ensure the Quarantine list is kept up to date

· Update/Maintain Conditional Approval Spreadsheet

· Ensuring 4th Shift Reject Bin is kept up to date

· Generate/Approve/Maintain Raw Material Conditional Approval Paperwork

· Issue MFG and PKG Records

· Update/Maintain/Email Production Schedule Spreadsheet

· Write & Issue lot specific stability protocols

· Create/Review/Approve Clinical COAs for Sovereign and RLD products.

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.