1142 IT & Software Developer jobs in the US
GMP Quality Assurance Validations Contractor
$87,000 - 111,000
DivIHN Integration Inc
North Corcoran Street 201, Durham
$87,000 - 111,000
Requirements
Must:
- Bachelors degree in a scientific discipline
- 5 years of experience in a GMP regulated environment in pharmaceutical, biotech, or biologics with at least 3 years in Quality and/or Manufacturing
- In-depth knowledge of GMP guidelines and Quality Systems, with capability to apply U.S. standards and regulatory authority guidelines
- Proficient in authoring, reviewing, and interpreting Standard Operating Procedures (SOPs)
- Proven ability to proactively identify and resolve quality issues in a diplomatic and constructive manner
- Exceptional attention to detail, highly organized, and capable of managing multiple tasks in a fast-paced environment
- Strong workload management skills to meet project deadlines
- Excellent verbal and written communication abilities, with the capacity to collaborate with technical colleagues
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
Responsibilities
- Collaborate with departmental clients to develop, implement, and integrate validation plans for equipment and computer systems onboarding
- Provide quality support through timely reviews and approvals of records, including Change Controls, SOPs, and validation plans
- Ensure QA activities are conducted within project timelines and escalate concerns as needed
- Report key metrics to promote continuous compliance improvement
- Participate in project meetings as a quality lead and act as a technical resource for quality and compliance issues
- Support Quality Systems within the companys QMS and GMPs, including SOP reviews and change control processes
- Communicate project statuses to stakeholders and promptly address any arising issues
Description
At DivIHN, a CMMI ML3-certified Technology and Talent solutions firm based in Research Triangle Park, NC, we pride ourselves on fostering meaningful connections between talented professionals and innovative companies. We have been serving both commercial and public sector organizations since 2002. Our goal is to build exceptional teams through temporary and permanent placements. This Validations Contractor position is integral to our GMP Quality Assurance efforts and includes minimal domestic travel. As part of our team, you will have the opportunity to contribute to our culture of quality and compliance.
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The company with most openings is Jobot as they are hiring for 58 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.
The company with most openings is Jobot as they are hiring for 58 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.