Quality Assurance Associate

Aditi Consulting; Winchester (KY); On-site; USD 34,440 - 38,572; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) with employer match

Health savings account

Paid time off

Bereavement leave

Commuter benefits

Discretionary bonus

Job summary

Aditi Consulting is seeking a compliance-focused professional to help assure adherence to SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceuticals. The role emphasizes accuracy, documentation integrity, and cross-functional collaboration.

Responsibilities include reviewing SOP revisions, conducting real-time batch record audits, performing environmental monitoring, and supporting CAPA-driven site improvements.

Qualifications

• Bachelor's degree; OR Associate's degree with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience.
• Strong attention to detail, excellent communication skills, ability to work in a team environment, and a proactive approach to problem-solving.

Responsibilities

• Recommend SOP and batch record changes as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits 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.
• Conduct 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 applicable to manufacturing.
• 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 to identify and resolve routine errors and prevent possible deviations.
• Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise, providing sufficient detail for a full investigation by the responsible department.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards).
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Enforce GMP Compliance and promote teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed.
• Support site process improvements, including training, efficiency projects, and implementation of CAPAs.
• Complete investigations of customer complaints.

Skills

Attention to detail

Communication skills

Teamwork

Problem-solving

Education

Bachelor's degree

Associate's degree with 1 year experience

High School Diploma/GED with 2 years experience

Tools

JD Edwards

Job description

Payrate: $26.38 - $26.38 /hour.

Summary: This position involves ensuring compliance with SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities:

• Recommend SOP and batch record changes as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits 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.
• Conduct 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 applicable to manufacturing.
• 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 to identify and resolve routine errors and prevent possible deviations.
• Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise, providing sufficient detail for a full investigation by the responsible department.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards).
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Enforce GMP Compliance and promote teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed.
• Support site process improvements, including training, efficiency projects, and implementation of CAPAs.
• Complete investigations of customer complaints.

Payrate: $26.38 - $26.38 /hour.

Summary: This position involves ensuring compliance with SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities:

• Recommend SOP and batch record changes as needed.
• Review proposed SOP revisions and provide feedback to management.
• Conduct real-time audits 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.
• Conduct 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 applicable to manufacturing.
• 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 to identify and resolve routine errors and prevent possible deviations.
• Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise, providing sufficient detail for a full investigation by the responsible department.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards).
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Enforce GMP Compliance and promote teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed.
• Support site process improvements, including training, efficiency projects, and implementation of CAPAs.
• Complete investigations of customer complaints.

Qualifications:

• Bachelor\'s degree; OR Associate\'s degree with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience.
• Strong attention to detail, excellent communication skills, ability to work in a team environment, and a proactive approach to problem-solving.

Pay Transparency: The typical base pay for this role across the U.S. is:$26.38 - $26.38/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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