Job Description

We are seeking a hands-on QC/QA Hybrid Manager to lead our quality control operations and compliance systems in a new peptide manufacturing lab. This role combines day-to-day QC supervision, batch review, and analytical oversight with strategic quality management , including SOP development, CAPA, and regulatory readiness.

The ideal candidate thrives in a startup environment , has experience with regulated laboratory operations , and is comfortable both mentoring staff and building robust quality systems from the ground up .

Key Responsibilities

Quality Control Operations

• Supervise QC testing workflows, including HPLC, LC-MS/MS, endotoxin, sterility, and CoA generation.
• Approve or reject batches for release in collaboration with production and analytical staff.
• Manage sample scheduling, instrument calibration, and lab documentation practices.
• Troubleshoot QC and analytical issues with the Lead Analytical Chemist.

Quality Management / Compliance

• Develop, implement, and maintain SOPs, batch records, change control, and CAPA processes .
• Ensure lab operations comply with cGMP, USP, FDA, and state Board of Pharmacy regulations .
• Lead regulatory and internal audits; prepare responses for inspections.
• Ensure data integrity, documentation accuracy, and environmental monitoring compliance .

Team Leadership

• Mentor and manage QC staff and lab technicians.
• Collaborate with Lead Analytical Chemist, Production Lead, and Lab Director to coordinate lab operations.
• Foster a culture of compliance, accountability, and continuous improvement .

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 5–10+ years in regulated lab environments with hands-on QC and quality oversight .
• Proven experience with HPLC, LC-MS/MS, sterility, and endotoxin testing .
• Strong knowledge of cGMP, USP, FDA regulations, and quality systems .
• Experience writing and reviewing SOPs, batch records, and CAPAs .
• Demonstrated leadership and team management experience.
• Excellent documentation, analytical, and problem-solving skills.

Preferred Qualifications

• Experience in 503B outsourcing facilities, sterile compounding, or injectable manufacturing .
• Prior exposure to FDA, State BOP, or third-party audits .
• Knowledge of peptide chemistry, lyophilization, and stability testing .
• Ability to work in a fast-growing startup lab environment .

Compensation & Benefits

• Salary: $115,000 – $145,000, depending on experience.
• Total Comp: Up to $160,000 with performance-based bonus.
• Health, Dental, Vision, 401K, Life Insurance, PTO.
• Opportunity to grow into Lab Director or QA leadership roles as the lab expands.
• Professional development support (conferences, certifications).

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