LanceSoft, Inc.
Base pay range
$22.00/hr - $26.40/hr Responsibilities
The QA Associate is responsible for the quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and client SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples. Specific Tasks, Duties and Responsibilities
Recommend SOP and
batch record
changes as needed Review proposed SOP revisions and provide feedback to management Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters Perform room and equipment clearances per procedure following cleaning conducted by production. Perform microbial swabbing of equipment and room surfaces for environmental monitoring. Maintain a full understanding of all client SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products. Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time. Essential Skills and Experience
Education or Experience: (Minimum required to perform job)
Preferred - Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience. Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment. Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
$22.00/hr - $26.40/hr Responsibilities
The QA Associate is responsible for the quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and client SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples. Specific Tasks, Duties and Responsibilities
Recommend SOP and
batch record
changes as needed Review proposed SOP revisions and provide feedback to management Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters Perform room and equipment clearances per procedure following cleaning conducted by production. Perform microbial swabbing of equipment and room surfaces for environmental monitoring. Maintain a full understanding of all client SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products. Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time. Essential Skills and Experience
Education or Experience: (Minimum required to perform job)
Preferred - Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience. Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment. Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications. Seniority level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr