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Randstad USA · 3 days ago

Lab Analyst (Associate II), Quality Control; (WED-SAT)

Norwood, MA

Contract

Onsite

Entry, Mid Level

$35/hr - $47.74/hr

2+ years exp

Randstad USA is seeking a Quality Control Associate II to support cGMP QC activities for raw materials, drug substances, and finished products. This role involves performing routine quality control Microbiology testing and ensuring compliance with cGMP standards while collaborating with cross-functional teams to maintain quality and efficiency in QC operations.

ConsultingHuman ResourcesInformation TechnologyRecruiting

H1B Sponsor Likely

Responsibilities

Conduct QC Microbiology routine testing including but not limited to bioburden, endotoxin, sterility, TOC, and enumeration

Maintain and troubleshoot laboratory equipment and manage QC lab supplies

Write, revise, and maintain SOPs, protocols, and reports

Participate in quality systems records such as deviations, change controls, CAPAs, and non-conformance investigations

Perform general laboratory support activities including equipment maintenance and housekeeping

Ensure compliance with cGMP documentation and regulatory guidelines

Establish and maintain a safe laboratory working environment

Provide support during internal and vendor audits and collaborate on continuous improvement initiatives

Qualification

MicrobiologyLaboratory Information Management Systems (LIMS)Aseptic TechniqueManufacturing Practices (GMP)FDA regulations knowledgeExperience in cGMP laboratoryTroubleshooting skillsCommunication skillsOrganizational abilities

Required

STEM degree with 2-3 years' of experience in a cGMP laboratory setting, with hands-on experience in microbiology techniques

Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP, eQMS)

Excellent troubleshooting skills and the ability to communicate scientific issues clearly

Strong written and oral communication skills and organizational abilities

Knowledge of GMP, microbiology, aseptic techniques and general laboratory instrumentation

Ability to handle multiple projects in a fast-paced environment

Familiarity with relevant FDA, EU, ICH guidelines, and regulations

Benefits

Medical

Prescription

Dental

Vision

AD&D

Life insurance offerings

Short-term disability

401K plan

Company

Randstad USA

Glassdoor3.8

Randstad US is a wholly owned subsidiary of Randstad Holding nv, a global provider of human resources solutions.

Founded in 1998

Atlanta, Georgia, USA

1001-5000 employees

http://randstadusa.com

H1B Sponsorship

Randstad USA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (754)

2022 (776)

2021 (1143)

2020 (1749)