Quality Assurance Specialist jobs in Lexington, KY
Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Specialist jobs
Quality Assurance Associate
- Abacus Service Corporation
-
Winchester, KY
CONTRACTOR,FULL_TIME
-
Description/Commen
- ONSITE - TEMP TO PERM - DURATION - 3-6 MONTHS TO CONVERT - SHIFT - MON - FRI 2PM - 10:30PM.
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.
II. Specific Tasks, Duties and Responsibilities:
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
" 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
III. Essential Skills and Experience:
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
Start Time:
12:00 AM
Hours:
8:00am to 5:00pm
Location:
110 1100 Enterprise Drive (phone number removed) Winchester KY 40391 United States
Education:
Additional Job Details:
- 22 Days Ago
Quality Assurance Associate
- ASC
-
Winchester, KY
OTHER,TEMPORARY
- PAY - $29.08/hr. - ONSITE - TEMP TO PERM - DURATION - 3-6 MONTHS TO CONVERT - SHIFT - MON - FRI 2PM - 10:30PM. The QA Associate is responsible for the Quality support functions associated with the man...
- 23 Days Ago
Senior Manager, Quality Assurance
- Bridgestone Americas
-
Williamsburg, KY
FULL_TIME
- Company OverviewFirestone Airide, specializes in air spring manufacturing and technology with a history of more than 80 years of research and development on technologically advanced air springs for th...
- Just Posted
Quality Assurance Lab Technician
- Sunset
-
Berea, KY
FULL_TIME
- Primary Responsibilities: Monitor and verify Critical control Points (CCPs) meet requirements and ensure any corrective actions are properly performed and recorded Conduct and support internal audits ...
- 10 Days Ago
Team Lead GPS Quality Assurance
- NiSource
-
Lexington, KY
FULL_TIME
- Description Job Title: Team Lead GPS QA Job Code: 107557 Job Summary The Team Lead GPS QA position leads a cross-functional team that has the responsibility for the continuous development, delivery, m...
- 20 Days Ago
Quality Specialist
- Jobot
-
Georgetown, KY
FULL_TIME
- Salaried Position / $Competitive Salary$ / PTO / 401K match / Full Benefits, Health, Dental, Vision This Jobot Job is hosted by: Natalie Hocevar Are you a fit? Easy Apply now by clicking the "Apply No...
- 9 Days Ago
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0 Quality Assurance Specialist jobs found in Lexington, KY area
Pharmaceutical Quality Control
- Acro Service Corporation
-
Winchester, KY
- Job Description Job Description We are seeking a Pharmaceutical Quality Control to join the company, a premier supplier,...
- 4/26/2024 12:00:00 AM
Quality Assurance Quality Control Microbiology Technician
- Danimer Scientific
-
Winchester, KY
- Benefits: 401(k) 401(k) matching Dental insurance Free uniforms Health insurance Paid time off Stock options plan Vision...
- 4/24/2024 12:00:00 AM
quality assurance associate
- Randstad US
-
Georgetown, KY
- quality assurance associate. georgetown , kentucky posted 8 days ago job details summary $13 per hour temporary category...
- 4/24/2024 12:00:00 AM
Quality Control Analyst
- Acro Service Corp
-
Winchester, KY
- RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO: • Perform efficient/reliable/high quality analytical testing in accord...
- 4/24/2024 12:00:00 AM
Quality Control Analyst I/II
- System One Holdings, LLC
-
Winchester, KY
- Title:Quality Control Analyst I/IIWeekend Start: ASAP Duration: 12 months Location: Winchester KY 40391 Schedule Friday ...
- 4/24/2024 12:00:00 AM
Manager, Quality Assurance
- Cardinal Health
-
Frankfort, KY
- **_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures...
- 4/23/2024 12:00:00 AM
Quality Assurance Manager
- KCO Resource Management
-
Lexington, KY
- Are you a quality assurance professional with food safety/quality experience in the salty snack industry? We are working...
- 4/22/2024 12:00:00 AM
QA/Expeditor - Richmond Road Chili's - No Experience Required
- Brinker International
-
Lexington, KY
- Role Overview Our Quality Assurance Specialists ensure each Guest receives perfectly prepared, high-quality food. They p...
- 4/22/2024 12:00:00 AM
About Lexington, Kentucky
Lexington, consolidated with Fayette County and often denoted as Lexington-Fayette, is the second-largest city in Kentucky and the 60th-largest city in the United States. By land area, Lexington is the 28th largest city in the United States. Known as the "Horse Capital of the World," it is the heart of the state's Bluegrass region. It has a nonpartisan mayor-council form of government, with 12 council districts and three members elected at large, with the highest vote-getter designated vice mayor. In the 2017 U.S. Census Estimate, the city's population was 321,959, anchoring a metropolitan are...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$57,185 to $72,398
Lexington, Kentucky area prices
were up 1.2% from a year ago
were up 1.2% from a year ago
What does a Quality Assurance Specialist do?
Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020