Manpower Engineering
QA Associate 1
Manpower Engineering, Winchester, Kentucky, us, 40392
Job title: QA Associate
Location-Winchester KY
Duration - 3 MONTHS
Shift - Mon-Fri 2PM-10:30PM
Education or Experience: •Bachelors 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.
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
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -
Manpower, Experis, Talent Solutions, and Jefferson Wells
- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Education or Experience: •Bachelors 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.
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
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -
Manpower, Experis, Talent Solutions, and Jefferson Wells
- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.