Quality Assurance Specialist - Torrance jobs in United States
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PolyPeptide Group · 6 hours ago

Quality Assurance Specialist - Torrance

PolyPeptide is a global leader in peptide-based active pharmaceutical ingredients, and they are seeking a QA Compliance Specialist I to maintain and strengthen GMP quality systems. This role involves supporting quality systems, documentation, training, and collaboration with various departments to ensure compliance with regulatory requirements.

Manufacturing
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H1B Sponsor Likelynote

Responsibilities

Support core quality systems including deviations, CAPAs, and document control
Assist with change controls, periodic reviews, document issuance, and reconciliation of records
Monitor site quality systems and help prepare annual summary reports for:
Environmental and water monitoring
Equipment qualification and validation activities
Preventive maintenance and trending programs
Support investigations, root cause analyses, and OOS/OOT events, ensuring documentation is compliant, thorough, and well-reasoned
Organize and archive records in accordance with retention policies and internal procedures
Support training and onboarding activities across departments
Maintain training records and ensure documentation is complete and audit-ready
Partner with Manufacturing, Development, Project Management, Regulatory Affairs, and Corporate Quality teams
Support internal and external audits, including preparation and follow-up activities
Contribute to site-wide efforts to maintain compliance with cGMP, FDA, and ICH guidelines
Perform additional duties as needed to support Quality and site operations

Qualification

CGMP principlesQuality systemsFDA regulatory expectationsCAPAsMulti-taskingCuriosityAccountabilityContinuous improvement mindsetAttention to detailOrganizational skillsWritten communicationVerbal communication

Required

Bachelor's degree in a scientific or technical discipline (Chemistry, Biology, Pharmaceutical Sciences, or similar)
1–3 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology environment
Solid understanding of cGMP principles and quality systems
Familiarity with FDA and ICH regulatory expectations
Strong attention to detail and organizational skills
Clear, effective written and verbal communication
Ability to manage multiple priorities in a fast-paced environment
Curiosity, accountability, and a continuous-improvement mindset

Preferred

Experience with deviations, CAPAs, or document control is a plus
Experience in peptide or oligonucleotide manufacturing is a plus, but not required

Company

PolyPeptide Group

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The PolyPeptide Group is a contract manufacturing organization for peptides and peptide related molecules.

H1B Sponsorship

PolyPeptide Group 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
2021 (2)

Funding

Current Stage
Public Company
Total Funding
$161.81M
2025-05-23Post Ipo Debt· $45.48M
2023-10-02Post Ipo Debt· $116.33M
2021-04-29IPO

Leadership Team

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Juan Jose Gonzalez
Chief Executive Officer
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El Djouhar RekaÏ
Head of Business Unit Peptide Process Development & Manufacturing
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Company data provided by crunchbase