Senior Investigator, Quality Assurance

Job Description

Job Description

The Senior Investigator, Quality Assurance is responsible for independently leading complex investigations, deviation management, customer complaints, CAPA development, and trending associated with clinical packaging, labeling, storage and distribution activities. This position serves as a subject matter expert for investigation excellence, root cause analysis, risk management, and continuous improvement initiatives in compliance with cGMP regulations and company quality standards.

POSITION REPORTS TO:

QA Compliance

POSITION SUPERVISES:

N/A

KEY RESPONSIBILITIES

• Independently lead and author investigations for deviations, operational events, customer complaints, and quality system events arising from clinical packaging, labeling, storage and distribution operations.
• Conduct comprehensive root cause analyses utilizing methodologies including 5 Whys, Fishbone, FMEA and risk-based approaches.
• Develop scientifically sound, risk-based conclusions supported by data and documented evidence.
• Facilitate the development, implementation and verification of effective corrective and preventive actions (CAPAs)designed to address systemic causes and reduce recurrence of quality events.
• Analyze and trend quality system data, including deviations, nonconformances, complaints, CAPAs, audit observations, and recurring events.
• Generate and present investigation, complaints and CAPA metrics to support Management Review and Quality Review Board meetings and continuous improvement activities.
• Perform risk assessments to evaluate potential impact to product quality, patient safety, compliance, and clinical supply continuity.
• Partner with Manufacturing, Supply Chain, Engineering, Validation, and Regulatory Affairs to resolve quality issues and drive continuous improvement.
• Identify systemic issues and recommend process improvements to reduce recurrence of quality events.
• Author, revise, and improve SOPs, work instructions, forms, and quality system documentation.
• Provide guidance and mentoring to site personnel regarding investigation techniques, root cause analysis, and CAPA effectiveness.
• Support Competent Authority, Client, Sponsor and regulatory inspections by providing investigation summaries, investigation rationale and evidence supporting quality system decisions.
• Support additional Quality Assurance activities and special projects as assi gned.

MINIMUM QUALIFICATIONS {KNOWLEDGE, SKILLS, AND ABILITIES)

• 3+ years of experience in Quality Assurance, Investigations, Compliance, or Quality Systems within a pharmaceutical, biotechnology, clinical packaging, clinical supply, CDMO, or highly regulated manufacturing environment.
• Proven ability to independently lead complex investigations and defend conclusions during audits and leadership review .
• Experience with electronic Quality Management Systems (e-QMS), including TrackWise, Veeva, ZenQMS, or equivalent platforms.
• Experience investigating deviations, nonconformances, complaints, temperature excursions, labeling events and distribution-related quality issues.
• Strong experience developing quality metrics and performing data analysis and trending.
• Knowledge of ICH guidelines, Quality Risk Management principles, and current industry expectations for investigations and CAPA programs.

SKILLS & COMPETENCIES

• Bachelor's degree or equivalent work experience
• Excellent interpersonal skills
• Excellent English reading and writing skills
• Excellent English communication skills
• Excellent problem solving/investigational skills
• Excellent mathematical skills
• Ability to work with others for problem solving and training
• Computer literacy skills, including basic knowledge of Microsoft® Word and Excel
• Attention to detail
• Effective time management skills
• Strong understanding of GMPs
• Familiarity with the pharmaceutical or food industry

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Some physical lifting as required maybe required. While performing the duties of this job, the employee maybe exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. Personal Protective Equipment (PPE) and associated training will be provided.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job­ related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.