Senior Quality Assurance Associate jobs in United States
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SPECTRAFORCE · 18 hours ago

Senior Quality Assurance Associate

positionHolly Springs, NC
timeFull-time
remoteOnsite
senioritySenior Level
money$30/hr - $33/hr

SPECTRAFOR is seeking a Senior Quality Assurance Associate to work directly with plant manufacturing and support groups in Holly Springs, NC. The role involves providing Quality oversight to ensure adherence to GMP quality requirements and facilitating real-time decision making for ongoing manufacturing operations and new product introductions.

ConsultingCRMInformation TechnologyLegal
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Aastha Puri
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Responsibilities

Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
Identification and implementation of continuous improvement opportunities within our processes and systems
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections

Qualification

Manufacturing experiencePQA backgroundCGMP knowledgeQuality oversightBatch records experienceDeviation managementContinuous improvementRegulatory interactionB.S. degreeProject management

Required

Manufacturing and PQA background
Previous work on GNP Facilities
PQA or Mfg preferably Drug Substance Experience
Previous work with Batch records/Deviations/Qa Oversight

Preferred

B.S. degree

Company

SPECTRAFORCE

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Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
dateFounded in 2004
location
Raleigh, North Carolina, USA
people-size1001-5000 employees
web-link
http://www.spectraforce.com

H1B Sponsorship

SPECTRAFORCE 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)

Funding

Current Stage
Late Stage
Company data provided by crunchbase