4 quality assurance associate Jobs in winchester, ky
intellectt is Hiring a Quality Assurance Associate Near Winchester, KY
Location: 1100 Enterprise Dr, Winchester, KY 40391
Duration: 06 MONTHS.
Timings: MON - FRI 2PM - 10:30PM.100% Onsite Role - TEMP TO HIREDescription
- 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.
- 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
IT Recruiter
Intellectt Inc
hima@intellectt.com, Contact No: 732-592-2008, Ext:454
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Job Summary
Full Time
Business Services
$78k-95k (estimate)
05/28/2024
07/28/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
The job skills required for Quality Assurance Associate include Quality Assurance, Analysis, SOP, Coaching, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Assurance Associate positions, which can be used as a reference in future career path planning. As a Quality Assurance Associate, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Associate. You can explore the career advancement for a Quality Assurance Associate below and select your interested title to get hiring information.
If you are interested in becoming a Quality Assurance Associate, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Assurance Associate for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Assurance Associate job description and responsibilities
Quality Assurance Associates conduct audits, training programs as well as documentation reviews and analysis.
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Collaborate with production team to monitor all work according to required quality system and evaluate all standard operating procedures and execute all compliance systems to ensure effectiveness of all programs.
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Prepare an efficient training program for all quality systems.
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Examined and compared given photos to ensure accuracy and required photos meet quality standards.
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Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Assurance Associate jobs
Quality Assurance Specialist roles will typically be looking for the skills previously outlined.
01/26/2022: Idaho Falls, ID
Step 3: View the best colleges and universities for Quality Assurance Associate.
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