We are seeking a collaborative, detail‑oriented, and safety‑focused QA/QC Manager to lead quality assurance and quality control activities across laboratory, pilot, and light production operations. The successful candidate will partner with R&D, operations, engineering, suppliers, and regulatory stakeholders to establish, maintain, and continuously improve quality systems that ensure product integrity, compliance, and safe operations. This role requires strong systems thinking, hands‑on quality program leadership, excellent communication, and a commitment to continuous improvement.

Key Responsibilities

• Develop, implement, and maintain the quality management system (QMS) including SOPs, work instructions, quality plans, and record‑keeping practices to meet internal and regulatory requirements.

• Design and execute QA/QC strategies for laboratory, pilot, and light industrial processes covering incoming inspection, in‑process controls, final release testing, and nonconforming material handling.

• Lead and coordinate inspections, audits, and supplier quality activities; perform vendor qualification, evaluate supplier performance, and manage corrective and preventive actions (CAPA) with suppliers and internal teams.

• Establish and maintain specification controls, test methods, acceptance criteria, sampling plans, and test protocols; ensure appropriate traceability and documentation for all quality activities.

• Develop, validate, and oversee analytical and functional test methods used for release and stability testing; collaborate with laboratory staff to ensure method robustness and reproducibility.

• Manage incoming material inspection and disposition, including quarantine processes, lot traceability, labeling, and storage controls to protect material integrity and chain of custody.

• Drive root cause investigations for product or process deviations using structured problem‑solving tools (e.g., 8D, fishbone, 5‑why) and implement effective corrective actions to prevent recurrence.

• Plan and execute internal audits and support external audits and regulatory inspections; prepare audit reports, track remediation, and ensure timely closure of findings.

• Monitor quality metrics and KPIs (e.g., defect rates, CAPA cycle times, supplier nonconformances); generate regular reports and present trends, risks, and improvement recommendations to leadership.

• Collaborate with engineering and operations on design reviews, change control, equipment qualification, FAT/SAT activities, and process validation to ensure manufacturability and quality by design.

• Develop and deliver quality training for technicians, operators, and engineers on quality procedures, inspection techniques, data integrity, and good documentation practices.

• Maintain document control, change control, and records management practices to ensure compliance with applicable standards and internal policies.

• Support product release decisions, oversee stability and shelf‑life programs where applicable, and manage disposition of nonconforming products in coordination with cross‑functional teams.

• Promote a culture of quality and safety by participating in continuous improvement initiatives, risk assessments (e.g., FMEA), and reliability efforts to improve yield, reduce variability, and enhance customer satisfaction.

• Mentor and develop quality staff; contribute to departmental standards, templates, and training materials to raise organizational capability.

Required Qualifications - Skills & Experience

• Bachelor’s degree in Chemistry, Biology, Engineering, Quality Management, or a related field, or equivalent professional experience.

• 5+ years of progressive QA/QC experience in laboratory, pilot, or light industrial environments with responsibility for quality systems, inspections, and supplier management.

• Proven experience developing and maintaining QMS documentation including SOPs, CAPA, change control, and audit programs.

• Strong experience with root cause analysis and corrective action methodologies; demonstrated ability to drive closure and verify effectiveness of fixes.

• Hands‑on familiarity with test method development and validation, analytical techniques, and sampling/statistical methods to support reliable quality decisions.

• Working knowledge of applicable standards and regulations relevant to lab and pilot operations (e.g., ISO 9001, GLP concepts, GMP principles where applicable) and good documentation practices.

• Experience managing supplier quality, incoming inspection, and lot traceability systems; ability to develop supplier scorecards and qualification criteria.

• Excellent written and verbal communication skills: able to prepare clear quality documentation, audit reports, and present findings to cross‑functional stakeholders.

• Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast‑paced environment while maintaining quality and compliance.

• Proficiency with quality tools and software (LIMS, EQMS, electronic document control, statistical analysis tools) and competency with ticketing and documentation systems.

Preferred Qualifications - Domain & Tools

• Advanced degree in a scientific or engineering discipline or relevant professional certifications (e.g., CQE, CQM‑ASQ, Six Sigma) are a plus.

• Experience with automated inspection systems, laboratory instruments, or high‑throughput testing environments preferred.

• Familiarity with statistical process control (SPC), design of experiments (DOE), FMEA, and other reliability/quality improvement methodologies.

• Experience supporting regulatory inspections or compliance programs and working with cross‑functional teams in regulated industries is advantageous.

• Certifications or training in ISO standards, auditing, or quality management systems are beneficial.

Work Environment & Compensation

• Full‑time position within an interdisciplinary quality, engineering, and operations organization; role combines office‑based quality systems work with regular hands‑on lab and pilot area activities.

• Competitive salary and benefits package commensurate with experience, including health coverage, retirement plan options, paid time off, and professional development support.

• Opportunities for training, certifications, conference participation, and career growth within a diverse, inclusive, and safety‑focused workplace.

• We are committed to diversity, equity, and inclusion and foster a respectful work environment that supports work‑life balance and employee well‑being.