Overview
NPI Quality Inspector Jobs in Fort Collins, CO at Advanced Energy Industries, Inc.
Almac Group is hiring a Validation Specialist for our Souderton, PA location. The Validation Specialist – Computerized Systems will work as part of the Quality department, you will be responsible for coordinating validation activities, at any Almac Clinical Services site, to ensure that simple computerized systems achieve compliance with business and regulatory requirements and to ensure their validated status is maintained throughout their operational lifetime.
Responsibilities include but are not limited to:
Ensure that quality, regulatory and GMP compliance are implemented and maintained during the validation of computerized system projects.
Ensure each new computerized system’s introduction is fully assessed and confirm a validation strategy is developed and managed to deliver all associated requirements to a high-quality standard and within pre-agreed timelines.
Validation Plans
Validation Protocols – including Traceability Matrices
Validation Summary Reports
Periodic Review Reports
Discovery Studies
Compile and co-ordinate the approval of validation documentation including:
Coordinate and support the execution of validation testing.
Ensure issues are addressed / escalated in a timely manner to minimize
Ensure any CAPA / Follow-up items assigned to you are actioned in a timely manner or that an Addendum is submitted if it is not possible to complete in line with the target completion date.
Maintain Aries with up-to-date project status details. any delays to projects.
Qualifications:
Required Experience / Education:
Associates Degree
1 year of general work experience
1 year of related validation/testing experience
Preferred Experience / Education:
Bachelor’s Degree
1 year working within an established pharmaceutical quality system (e.g., QA, Validation, or software testing role)
GxP regulations
Practical knowledge of validation and related activities
What Almac Group can offer YOU!
Full medical, vision & dental benefits the 1st of the month after start date
20 days of PTO to start plus 12 holidays per year
Company paid long and short term disability along with life insurance
401k company match
Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer – Minorities/Women/Protected Veterans/Disabled – Proudly embracing diversity in all of its expressions.
EEO is the Law
EEO is the Law GINA Supplement
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
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Title: NPI Quality Inspector
Company: Advanced Energy Industries, Inc.
Location: Fort Collins, CO
