Quality Assurance Manager – Peptides

HR MGMT 10, LLC

Employer: HR MGMT 10, LLC

Location: Tustin, CA

Employment Type: Full Time

FLSA Classification: Exempt

Department: Quality Control / Peptides

Reports To: Director of R&D / VP of Operations

Direct Reports: QC Specialists, Lab Technicians

Position Summary

HR MGMT 10, LLC is an Employer of Record providing workforce support services to partnered brands operating in regulated and consumer product industries. The Quality Assurance Manager – Peptides leads all quality assurance and control functions across the peptide manufacturing operation, from incoming materials through finished goods release. This role is responsible for managing QC personnel, ensuring regulatory compliance, and driving continuous improvement to uphold the highest standards of product integrity and safety. The QA Manager serves as the primary quality authority on the production floor and partners cross-functionally with R&D, Operations, and Regulatory Affairs. This role is integral in building this company from a stage 0 startup into a viable, self sustaining research chemical manufacturing facility.

Core Responsibilities

1. QC Team Leadership & Management

• Supervise, mentor, and develop QC Specialists, Lab Technicians, and support staff

• Set performance expectations, conduct reviews, and manage daily team scheduling and workload

• Foster a culture of quality, accountability, and continuous improvement across the QC department

• Identify staffing needs and participate in recruitment, onboarding, and training of QC personnel

2. Incoming Materials & Supplier Quality

• Oversee review and approval of incoming materials, Certificates of Analysis (COAs), and supplier documentation

• Establish and maintain supplier qualification standards and audit programs

• Make final disposition decisions (release, quarantine, or reject) on incoming raw materials

• Manage supplier corrective action requests (SCARs) and track resolution to closure

3. Lab Testing & Third-Party Coordination

• Manage relationships with third-party testing laboratories; negotiate contracts and turnaround timelines

• Oversee sample submission protocols, Chain of Custody (COC) documentation, and COA review processes

• Ensure all testing methods and specifications are current, validated, and aligned with regulatory requirements

• Monitor and report on testing trends, OOS results, and lab performance metrics

4. Production Quality Oversight

• Establish and enforce Critical-to-Quality (CTQ) parameters including fill weight, airflow, seal/closure integrity, and reject rates

• Authorize production holds, investigations, and resumption based on quality findings

• Lead or delegate root cause analysis for deviations, non-conformances, and customer complaints

• Ensure QC presence and oversight throughout all manufacturing operations

5. Finished Goods Release & Regulatory Compliance

• Own the batch release process; approve or hold finished products for distribution

• Ensure all labeling, packaging, and batch/UID documentation meets applicable regulatory requirements

• Maintain current knowledge of federal and state regulations governing peptide products

• Serve as primary QC contact during regulatory inspections, audits, and third-party assessments

6. Documentation & Quality Systems

• Oversee maintenance of QC logs, Batch Production Records (BPRs), COAs, COC forms, and calibration records

• Ensure all documentation is complete, accurate, audit-ready, and retained per applicable requirements

• Manage QC data within ERP and quality management systems; identify opportunities for process efficiency

• Develop and enhance quality systems as needed.

7. SOPs & Continuous Improvement

• Lead development, revision, and training of Standard Operating Procedures (SOPs) across QC and production

• Own the deviation management, CAPA, and change control programs

• Drive continuous improvement initiatives leveraging data, KPIs, and cross-functional collaboration

• Present quality metrics and improvement roadmaps to senior leadership on a regular cadence

Qualifications

Required

• 5 years of experience in quality control, quality assurance, or related role within pharmaceutical, nutraceutical, or regulated manufacturing

• 2 years in a supervisory or people management capacity

• Hands-on experience with laboratory testing, COA review, batch record management, and regulatory documentation

• Demonstrated ability to lead investigations, write CAPAs, and drive corrective action to closure

• Strong working knowledge of GMP, GDP, and applicable quality system frameworks

Strongly Preferred

• Experience in peptide manufacturing, lyophilization, or sterile/aseptic processing environments

• Familiarity with FDA regulations and state-level compliance requirements for peptide or pharmaceutical products

• Experience managing third-party lab relationships and supplier qualification programs

• Proficiency with ERP systems and quality management software

Skills & Systems

• Exceptional leadership, communication, and cross-functional collaboration skills

• Strong analytical mindset with ability to interpret complex data and translate findings into actionable decisions

• Proficient in Google Workspace; comfortable with ERP platforms for data tracking and reporting

• Ability to manage multiple concurrent workflows across production, lab coordination, and compliance

• Basic math skills for potency calculations, batch consistency, and COA interpretation

What Success Looks Like

• All incoming materials, in-process checks, and finished goods are reviewed and dispositioned on time with zero release errors

• QC team is high-performing, well-trained, and operates effectively with clear direction and accountability

• Deviations and non-conformances are resolved quickly with effective CAPAs that prevent recurrence

• The QC department consistently passes internal and third-party audits with minimal findings

• Quality metrics are tracked, reported to leadership, and trending in the right direction quarter over quarter

Compensation & Benefits

Base Salary starting at $40/hr

Placement within the range is based on experience, demonstrated quality management expertise, and relevant industry knowledge.

Eligible employees may also receive:

• Performance-based incentives tied to departmental and organizational quality KPIs

• Equity or long-term incentive participation (if applicable)

• Access to company-sponsored benefits in accordance with HR MGMT 10, LLC plans and eligibility requirements

Work Environment & Physical Requirements

• Ability to sit, stand, walk, and use hands for extended periods

• Ability to work in laboratory and production floor environments, including use of PPE as required

• Occasional exposure to chemical compounds and regulated environments

• Ability to perform essential job functions with or without reasonable accommodation

Employment Relationship & Legal Notices

Employment with HR MGMT 10, LLC is at will and may be terminated by either party at any time with or without cause or notice in accordance with applicable law.

This job description does not create an employment contract.

HR MGMT 10, LLC complies with all applicable federal, state, and local employment laws.

Equal Employment Opportunity Statement

HR MGMT 10, LLC is an equal opportunity employer and does not discriminate based on any protected characteristic under applicable law.