Kelly Science, Engineering, Technology & Telecom
Quality Assurance Specialist
Kelly Science, Engineering, Technology & Telecom, Houston, Texas, United States, 77246
" This is a great opportunity for an experienced QA professional to grow within a supportive, people-focused pharmaceutical manufacturing environment.
Title:
Quality Assurance Specialist Salary:
$25-28.00/hr. + Benefits Responsibilities
Perform initial, in-process, and final inspections during manufacturing/packaging; resolve findings with Packaging or QA Management. Collect and label samples for release, validation, stability, and raw material testing; prepare and forward documentation to QC as needed. Monitor incoming materials in Quarantine; review receiving paperwork for accuracy and follow up on missing or incomplete CofAs. Inspect and approve/reject raw materials and components, including bottles, closures, cartons, and labels, verifying results with a second QA employee and updating system records accordingly. Prepare approval/rejection documentation, issue batch numbers, and assemble batch folders; coordinate with QA Manager on validation/stability designations. Issue batch documentation to production and review completed batch records for accuracy, resolving discrepancies with Production. Investigate material usage or yield discrepancies and assist in determining product disposition, including handling bright stock when applicable. Communicate product release status to Shipping and perform final pallet inspections to verify product name, lot, count, and order accuracy. Perform other related duties as required. Qualifications
Bachelor’s degree in a scientific discipline or equivalent combination of education and experience. 1+ year experience in quality assurance environment associated with manufacturing. Strong working knowledge of Good Manufacturing Practice (GMP) requirements, Standard Operating Procedures (SOP’s), and Department Operating Procedures (DOP’s). Excellent verbal and written communication skills. Able to read, analyze, and interpret government regulations, write clear reports, and effectively present information and respond to questions. Able to interpret a variety of instructions furnished in written, verbal, diagram, or schedule form. Solid working knowledge of creation and management of documents in Microsoft Excel and Word program. Good methodical organizational skills. Able to work in a team structure. Equal opportunity employer offering medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws. Seniority Level
Associate Employment Type
Full-time Job Function
Quality Assurance, Science, and Manufacturing Industries
Pharmaceutical Manufacturing " #J-18808-Ljbffr
Quality Assurance Specialist Salary:
$25-28.00/hr. + Benefits Responsibilities
Perform initial, in-process, and final inspections during manufacturing/packaging; resolve findings with Packaging or QA Management. Collect and label samples for release, validation, stability, and raw material testing; prepare and forward documentation to QC as needed. Monitor incoming materials in Quarantine; review receiving paperwork for accuracy and follow up on missing or incomplete CofAs. Inspect and approve/reject raw materials and components, including bottles, closures, cartons, and labels, verifying results with a second QA employee and updating system records accordingly. Prepare approval/rejection documentation, issue batch numbers, and assemble batch folders; coordinate with QA Manager on validation/stability designations. Issue batch documentation to production and review completed batch records for accuracy, resolving discrepancies with Production. Investigate material usage or yield discrepancies and assist in determining product disposition, including handling bright stock when applicable. Communicate product release status to Shipping and perform final pallet inspections to verify product name, lot, count, and order accuracy. Perform other related duties as required. Qualifications
Bachelor’s degree in a scientific discipline or equivalent combination of education and experience. 1+ year experience in quality assurance environment associated with manufacturing. Strong working knowledge of Good Manufacturing Practice (GMP) requirements, Standard Operating Procedures (SOP’s), and Department Operating Procedures (DOP’s). Excellent verbal and written communication skills. Able to read, analyze, and interpret government regulations, write clear reports, and effectively present information and respond to questions. Able to interpret a variety of instructions furnished in written, verbal, diagram, or schedule form. Solid working knowledge of creation and management of documents in Microsoft Excel and Word program. Good methodical organizational skills. Able to work in a team structure. Equal opportunity employer offering medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws. Seniority Level
Associate Employment Type
Full-time Job Function
Quality Assurance, Science, and Manufacturing Industries
Pharmaceutical Manufacturing " #J-18808-Ljbffr