Jt471- Specialist QA
Quality Consulting GroupJuncos, Puerto Rico
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Overview
Schedule
Alternate-schedule
Full-time
Career level
Senior-level
Remote
On-site
Benefits
Paid Holidays
Career Development
Job Description
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.Responsibilities:
- Perform quality disposition decisions (approval/rejection) for bulk drug substances in compliance with regulatory standards.
- Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
- Ensure all deviations are properly identified, investigated, documented, and resolved according to procedures.
- Ensure that changes that could potentially impact drug substance quality are assessed according to procedures
- Verify that production records and laboratory results are complete, accurate, and compliant with established procedures.
- Ensure facilities, equipment, materials, and processes meet regulatory and quality requirements.
- Lead and support continuous improvement initiatives, driving operational efficiency and quality enhancements.
- Collaborate cross-functionally to ensure Quality Management System (QMS) processes are properly executed.
- Support and participate in internal and external audits and regulatory inspections, serving as a Quality representative when needed.
- Provide quality oversight and support for New Product Introduction (NPI) activities.
- Bachelor’s degree in Life Sciences or Engineering
- 4+ years of directly related QA experience in a regulated manufacturing environment
- Experience performing batch record (EBR) review, approval, and reconciliation
- Experience as Manage events and decision making
- Oversight manufacturing operations (during a 12-hour night shift (5:00 PM – 5:30 AM), providing rotating coverage that includes weekends and holidays.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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FAQs About Jt471- Specialist QA Jobs at Quality Consulting Group
What is the work location for this position at Quality Consulting Group?
This job at Quality Consulting Group is located in Juncos, Puerto Rico, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Quality Consulting Group?
Employer has not shared pay details for this role.
What employment applies to this position at Quality Consulting Group?
Quality Consulting Group lists this position under the following employment categories:
- Alternate-schedule
- Full-time
What experience level is required for this role at Quality Consulting Group?
Quality Consulting Group is looking for a candidate with "Senior-level" experience level.
What benefits are offered by Quality Consulting Group for this role?
Quality Consulting Group offers following benefits: Paid Holidays and Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Quality Consulting Group?
You can apply for this role at Quality Consulting Group either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.