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GxP/GMP Lab Scientist (On-Site)(No H-1B or Corp to Corp)(Local candidates preferred)
Quick Overview
Seniority
Mid Senior
Work mode
On Site
Location
Malvern, PA, United States
Posted
Yesterday
ComplianceMicrosoft OfficeProcurement
Job Description
Please note that this is a 6 Month Contract position and is On-Site. No H1-B or Corp to Corp. Local candidates preferred.
JOB DESCRIPTION:
Top Skills:
- Role will be ONSITE, Mon-Fri regular working hours
- 6 month contract for now
- Bachelors degree required
- Role is Site Lead for Laboratory Services, will oversee contractors from certain contracting agencies
- Will oversee the day to day onsite operations
- Must have at least 3 years of experience in lab bench / lab operations required
- Scientifics background is required
- Exp in GxP/GMP environment bkg
- Must have Pharma and/or Biotech exp required
- Will participate in a lot of meetings
- Will act as the in between with Scientific and Engineers
- Will repond to a lot of emails and instant messages
Required Minimum Education: BS degree in biological or chemical science
Required Knowledge, Skills and Abilities:
• 3+ years of lab bench and/or lab operations experience in pharma/biotech laboratories
• Demonstrated experience with overseeing external vendor and strategic partner relationships
• Demonstrated ability to establish strong internal stakeholder relationships, lead through influence, and approach the role with a customer service mindset
• Strong organizational skills and attention to detail
• Strong skills in Microsoft Office applications, including Outlook and Teams
• Working knowledge of GxP environments, quality & compliance domain, and industry regulations (FDA, ISO OSHA)
• Demonstrated experience with overseeing external vendor and strategic partner relationships
• Demonstrated ability to establish strong internal stakeholder relationships, lead through influence, and approach the role with a customer service mindset
• Strong organizational skills and attention to detail
• Strong skills in Microsoft Office applications, including Outlook and Teams
• Working knowledge of GxP environments, quality & compliance domain, and industry regulations (FDA, ISO OSHA)
Required Years of Related Experience: At least 3 years’ experience in laboratory sciences and/or laboratory operations within pharma/biotech R&D, experience in GxP environment
Position Summary:
The Site Lead will be responsible for oversight and flawless execution of the enterprise Laboratory Services program for the Malvern location. The Laboratory Services program delivers strategic and operational value for stakeholders via central oversight of lab equipment maintenance (ELIS program), lab support contractor services, and point-of-use consumables management.
• Oversee general day-to-day operations of Laboratory Services programs on-site.
• Act as a key point of contact for business and strategic partners for laboratory needs and support.
• Oversee multiple vendor relationships that are responsible for delivering the Lab Services program in a GxP environment.
• Ensure laboratory services are aligned with safety standards, regulatory requirements, and quality systems, including appropriate trainings.
• Implementation of comprehensive strategies for laboratory equipment maintenance, supplies procurement, and lab support services to optimize operational efficiency.
• Follow-up on performance of Lab Services program with site-based teams
• Collaborate with local and site-based partner leads and teams to define and implement improvement plans when required.
• Oversee general day-to-day operations of Laboratory Services programs on-site.
• Act as a key point of contact for business and strategic partners for laboratory needs and support.
• Oversee multiple vendor relationships that are responsible for delivering the Lab Services program in a GxP environment.
• Ensure laboratory services are aligned with safety standards, regulatory requirements, and quality systems, including appropriate trainings.
• Implementation of comprehensive strategies for laboratory equipment maintenance, supplies procurement, and lab support services to optimize operational efficiency.
• Follow-up on performance of Lab Services program with site-based teams
• Collaborate with local and site-based partner leads and teams to define and implement improvement plans when required.
Candidates must provide their phone number. Job reference code is A5564.
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