QC/QA Project Manager

Job Description

Job Description

Applied Laboratories is seeking a highly organized and detail-oriented QC/QA Project Manager to join our Technical Services team. This position is responsible for coordinating quality projects involving customer complaints, controlled documents, specifications, audits, product release activities, CAPA programs, regulatory support, and quality systems improvement initiatives.

The ideal candidate will possess a strong quality background, excellent project management skills, and the ability to effectively coordinate activities across Quality Control, Quality Assurance, Manufacturing, Regulatory, and Customer Service functions. This role is well-suited for an experienced quality professional looking to expand their scope and influence within a growing regulated manufacturing environment.

Essential Duties and Responsibilities

• Manage customer and product complaints from intake and logging through investigation, response, documentation, and closure.
• Implement, maintain, and continuously improve the Master Specification Program, including specification creation, revision, approval, organization, and maintenance.
• Create, revise, route, and maintain SOPs, work instructions, specifications, and other Quality Management System (QMS) documentation.
• Support internal and external audits, complete follow-up activities, and conduct audits when qualified.
• Review and approve Certificates of Analysis (COAs) and Certificates of Conformance (COCs) for product release within delegated authority.
• Serve as a primary point of contact for customer quality requests, documentation needs, quality meetings, and follow-up activities.
• Manage CAPA and Change Control programs, including root cause analysis, tracking, implementation, and closure.
• Coordinate Annual Product Reviews and Management Reviews, including data collection, analysis, reporting, and distribution.
• Support and expand risk management initiatives across the quality system.
• Lead projects that improve electronic quality systems and support compliance with 21 CFR Part 11 requirements.
• Support regulatory filings and quality-related documentation activities as trained.
• Assist Quality Control operations with new projects, products, investigations, and quality improvement initiatives.
• Coordinate cross-functional projects to ensure timely completion, regulatory compliance, and achievement of organizational objectives.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in Chemistry, Biology, Quality, Life Sciences, Engineering, or a related field preferred. Equivalent experience will be considered.
• Three or more years of experience in Quality Assurance, Quality Control, complaint management, document control, auditing, laboratory operations, regulatory affairs, or regulated manufacturing environments preferred.
• Knowledge of cGMP requirements, quality systems, controlled documentation, investigations, specifications, CAPA programs, and product release processes.
• Experience supporting audits, customer quality inquiries, quality improvement initiatives, or compliance programs preferred.
• Strong project management, organizational, analytical, and problem-solving skills.
• Ability to evaluate technical information, identify risks, support investigations, and prepare accurate, defensible documentation.
• Strong communication, customer service, and stakeholder management skills.
• Proficiency in Microsoft Office 365 and electronic quality management systems.
• Experience in pharmaceutical, dietary supplement, food, cosmetics, medical device, chemical, or other regulated manufacturing environments is highly desirable.

Work Environment

This position operates primarily within office and laboratory environments, with regular interaction in manufacturing, warehouse, and production areas. Employees must comply with all safety, quality, cGMP, sanitation, and PPE requirements. The role may require standing, walking, sitting, carrying documents or samples, and occasional exposure to manufacturing equipment, chemicals, noise, and varying environmental conditions.

Why Join Applied Laboratories?

Applied Laboratories continues to grow its quality systems, technical capabilities, and customer partnerships. This position offers a unique opportunity to make a meaningful impact on quality operations while leading projects that strengthen compliance, customer satisfaction, operational effectiveness, and continuous improvement.

This role is an excellent fit for:

• A Quality Assurance or Quality Control professional seeking broader project ownership and cross-functional exposure.
• A Document Control, CAPA, Audit, or Compliance specialist looking to expand into quality leadership responsibilities.
• A quality professional who enjoys managing multiple projects, solving complex problems, and driving process improvement.
• An individual seeking long-term career growth within a regulated manufacturing environment.

Applied Laboratories, Inc. is an Equal Opportunity Employer. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.