SRG Government Services
QA Analyst
SRG Government Services, Lexington, KY, United States
QA ASSOCIATE 1
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Position Summary:
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 SOP)
through document review/approval, real time monitoring/approval of manufacturing activities
and testing/approval of in-process and finished product samples.
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 teamwork 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:
• Bachelor's Degree in related science or technical field preferred with 2 years prior work
experience
• Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP
manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.
Knowledge/Skills 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
EOE/ADA
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: QA ASSOCIATE 1
- Location: Winchester, KY
- Industry: Pharmaceutical
- Hours: SHIFT - MON-FRI - 2PM-10:30PM
- Salary: up to $26.44 (Paid Weekly - Benefits Available)
- Employment Type: Contract to hire
Position Summary:
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 SOP)
through document review/approval, real time monitoring/approval of manufacturing activities
and testing/approval of in-process and finished product samples.
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 teamwork 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:
• Bachelor's Degree in related science or technical field preferred with 2 years prior work
experience
• Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP
manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.
Knowledge/Skills 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
EOE/ADA