Quality Assurance Associate

About Client:
As the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world, Company conduct all its business responsibly and with integrity. Our customers, investors and suppliers count on it, and our company’s continued success depends on it.
With broad, deep-scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, company is a preferred Contract Development and Manufacturing Organization (CDMO) partner for personalized medicines, blockbuster drugs and consumer health brand extensions.
Rate Range: $20-$29.08/Hr
Job Description:

• 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.

Roles 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

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
• Demonstrates initiative

Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
 
 
About ApTask:
Join ApTask, a global leader in workforce solutions and talent acquisition services, as we shape the future of work. We offer a comprehensive suite of offerings, including staffing and recruitment services, managed services, IT consulting, and project management, providing unparalleled opportunities for professional growth and development. As a member of our dynamic team, you'll have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success for our clients across diverse industries. If you are passionate about excellence, collaboration, and innovation, and aspire to make a meaningful impact in the world of work, come join us at ApTask and be a part of our mission to empower organizations to thrive.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
 
Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com