Top 4 Manufacturing quality assurance specialist Jobs in Paris, Ky

Manufacturing Quality Assurance Specialist
Piramal Pharma Solutions —Lexington, KY
- $23.12 - $27.50 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Disability insurance
Quick Apply
Manufacturing Quality Assurance Specialist II - 2nd Shift
Kindeva Drug Delivery Careers —Lexington, KY
- Full-time
- Mid-level
Quick Apply
EXPANSION Validation Specialist
Piramal Pharma Solutions Inc. —Lexington, KY
- Mid-level
- 2 years
- Communication skills
4d
Electrical Quality Control Specialist
Goodall Brazier —United States
- $180,000 - $235,000 a year
- Full-time
- Continuous improvement
- Senior level
- Communication skills
- Health savings account
- Health insurance
Quick Apply
12d

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Manufacturing Quality Assurance Specialist II - 2nd Shift
Kindeva Drug Delivery Careers —Lexington, KY
The Impact You Will Make: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of…
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Manufacturing Quality Assurance Specialist

Piramal Pharma Solutions -
Lexington, KY

Quick Apply

Job Details

Full-time
$23.12 - $27.50 an hour

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Referral program
Retirement plan

Qualifications

Microsoft Excel
Pharmaceutical regulatory compliance
Safety regulations
Manufacturing facility experience
Bachelor's degree
Attention to detail
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Cleanroom experience
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Company Overview
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) dedicated to providing comprehensive development and manufacturing solutions across the entire drug lifecycle. With a global network of facilities, we serve clients worldwide through innovative services in drug discovery, process development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms.

Job Overview

Reporting to the Quality Supervisor, he primary purpose of the MQA Specialist 0.role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).

Reporting Structure

This position reports to the Quality Supervisor.

Key Responsibilities:

Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP’s.
Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
Sampling and lab testing of the utilities including water, steam, and compressed gases.
Perform plate enumeration and documentation of the results.
Assist in the performance and documentation for cleaning verification sample collection and analysis.

Participates in audits and involve in onsite client interactions as needed by management.
Maintain laboratory instrumentation required for testing including calibrations.
Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
Participate in Microbiology material inventory control for EM media plates.
Prepare and summarize data associate with site metrics, write, read, and revise SOP’s QA and EM, technical reports.
Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.

Qualifications:

Bachelor's Degree in physical or biological sciences or related scientific field preferred.

1 years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA

Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
Demonstrated ability to effectively communicate both verbally and in writing
Ability to read and follow written instructions
Detail oriented
Understanding of sterile manufacturing preferred
Technical writing skills preferred

Pay: $23.12 - $27.50 per hour

Benefits:

401(k)
401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Referral program
Retirement plan
Tuition reimbursement
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

manufacturing quality assurance specialist jobs in paris, ky

Manufacturing Quality Assurance Specialist

Manufacturing Quality Assurance Specialist II - 2nd Shift

EXPANSION Validation Specialist

Electrical Quality Control Specialist

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