Planet Pharma
Position Overview
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 Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
Job Description Pay: 26.40/hr
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 Catalent 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.
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
Other assignments as needed within the scope of QA Associate training curriculum.
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance.
Promotes team work and good communication.
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
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.
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
Familiarity with basic laboratory instrumentation
Safe work habits
Basic math and computer skills
Good communication skills
Ability to follow written and verbal instructions
Able to work with limited supervision for routine tasks
Excellent documentation and handwriting skills
Proficient reading and comprehension skills
Sound decision-making, technical and problem solving skills
Good time management skills
Expert technical writing and problem solving skills
Good Laboratory Practices
Experienced with continuous improvement techniques
Demonstrates initiative
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Job Description Pay: 26.40/hr
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 Catalent 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.
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
Other assignments as needed within the scope of QA Associate training curriculum.
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance.
Promotes team work and good communication.
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
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.
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
Familiarity with basic laboratory instrumentation
Safe work habits
Basic math and computer skills
Good communication skills
Ability to follow written and verbal instructions
Able to work with limited supervision for routine tasks
Excellent documentation and handwriting skills
Proficient reading and comprehension skills
Sound decision-making, technical and problem solving skills
Good time management skills
Expert technical writing and problem solving skills
Good Laboratory Practices
Experienced with continuous improvement techniques
Demonstrates initiative
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr