QA Associate 1

Aditi Consulting

Winchester (KY)

On-site

USD 33,062 - 36,368

Part time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

Medical, dental, and vision benefits

10 paid days off

401(k) plan participation

Commuter benefits

Life and disability insurance

Job summary

Aditi Consulting is seeking a QA Associate to ensure quality support functions in pharmaceutical manufacturing. Responsibilities include overseeing operations according to cGMP guidelines, conducting audits and product testing. Candidates should have a Bachelor’s degree in a related field and relevant GMP experience. The role offers competitive hourly pay and opportunities for professional development.

Qualifications

Preferred Bachelor’s Degree in related science or technical field.
Minimum High School Diploma with relevant GMP experience.
Lean Six Sigma or ASQ certification is a plus.

Responsibilities

Oversee manufacturing operations and monitor activities per cGMP standards.
Perform routine testing of in-process and finished product samples.
Manage quality status of WIP and finished materials.

Skills

Familiarity with basic laboratory instrumentation

Good communication skills

Ability to follow written and verbal instructions

Good documentation and handwriting skills

Sound decision-making

Good Laboratory Practices

Education

Bachelor’s Degree in related science or technical field

High School Diploma with 4+ years of relevant work experience

Job description

This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$24.00/hr - $26.40/hr

Payrate: $24.00 - $26.40/hr.

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 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 with SOP/cGMP/batch record and safety requirements 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 Track wise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the department responsible 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 the QA Associate training curriculum.
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance.
Promote 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

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 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 with SOP/cGMP/batch record and safety requirements 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 Track wise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the department responsible 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 the QA Associate training curriculum.
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance.
Promote 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

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 management skills
Expert technical writing and problem-solving skills
Good Laboratory Practices

Education or Experience:

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.

Pay Transparency: The typical base pay for this role across the U.S. is: $24.00 - $26.40/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( https://www.aditiconsulting.com/privacy-policy ).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.

#AditiConsulting
#25-20827

Seniority level