Quality Investigations Coach

Job Title:

Quality Investigations Coach Job Description The Quality Investigations Coach is responsible for reviewing, mentoring, and elevating the quality of deviation and investigation records within a GMP-regulated environment. This role serves as a subject matter expert in investigative writing and root cause analysis, partnering closely with Quality, Manufacturing, and other cross-functional teams to ensure investigations are thorough, compliant, and inspection-ready. Unlike a traditional investigator role, this position focuses on coaching, quality oversight, and the continuous improvement of investigation practices across the organization, helping to reduce backlog and support timely delivery of critical products to patients. Responsibilities Review deviations, CAPAs, and investigation reports to ensure clarity, completeness, and compliance with GMP, FDA, and internal quality standards. Provide detailed, constructive feedback to investigators to improve technical writing quality, investigation structure, and documentation practices. Identify trends and recurring gaps in investigations and drive continuous improvement initiatives to strengthen investigation quality and consistency. Serve as a coach and mentor to Quality Investigators and cross-functional partners, providing real-time guidance on root cause analysis, investigation storytelling, and regulatory expectations. Support the onboarding and development of new investigators by sharing best practices and modeling high-quality investigative writing and reasoning. Drive consistency and standardization in investigation approaches, documentation formats, and quality expectations across the site. Support the development, refinement, and implementation of investigation templates, SOPs, and best practices to enhance investigation excellence. Partner with Quality leadership to elevate site-wide investigation capabilities and promote a strong quality and compliance culture. Collaborate closely with Quality Assurance, Manufacturing/Operations, and Engineering to align on investigation outcomes and effective corrective and preventive actions. Facilitate cross-functional agreement on root causes, CAPAs, and follow-up activities to ensure robust and sustainable solutions. Act as a key partner during internal audits and regulatory inspections, helping to present and defend investigation quality and outcomes. Identify systemic issues revealed through deviations and investigations and recommend process improvements to prevent recurrence. Support inspection readiness activities by ensuring investigations and related documentation are complete, accurate, and audit-ready. Ensure alignment with GxP and data integrity standards in all investigation-related activities and documentation. Leverage electronic quality management systems (eQMS) to review, track, and oversee deviation and investigation records efficiently. Essential Skills Bachelor's degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience. 7-10+ years of experience in a GMP-regulated environment such as pharmaceutical, biotechnology, or medical device manufacturing. At least 2+ years of experience supporting operations-based deviations and quality investigations in a GMP manufacturing environment. Proven ability to independently write and close investigations tied to manufacturing processes. Strong background in deviation investigations and CAPA management. Hands-on experience with root cause analysis methodologies, such as 5 Whys and Fishbone (Ishikawa) analysis. Deep understanding of GMP, FDA, and regulatory expectations related to deviations, investigations, and CAPAs. Strong understanding of batch record review, manufacturing workflows, and GMP documentation practices. Experience working in electronic quality systems (eQMS), including platforms such as Veeva Vault. Experience reviewing or approving investigations for quality and compliance. Excellent technical writing skills, with the ability to clearly and logically present investigation narratives and conclusions. Strong critical thinking skills, with the ability to analyze complex issues and identify true root causes. Effective stakeholder communication skills, with the ability to influence and guide cross-functional partners. Demonstrated knowledge of GMP, GxP, and data integrity principles as they relate to investigations and documentation. Additional Skills & Qualifications Prior experience in a coaching, mentoring, or quality oversight role focused on investigations or CAPAs. Experience supporting regulatory inspections or internal and external audits related to quality systems and investigations. background in Quality Assurance or Quality Systems within a GMP-regulated environment. Familiarity with electronic quality systems such as TrackWise and Veeva, in addition to other eQMS platforms. Experience with compliance-focused tools and systems used to manage deviations, CAPAs, and investigations. Ability to identify systemic process issues and recommend practical, risk-based improvements. Strong collaboration skills and the ability to work effectively with Quality, Manufacturing, Operations, and Engineering teams. Motivation to support critical backlog reduction work and contribute to getting mission-critical products to patients on time. Work Environment This role operates within a pharmaceutical manufacturing environment, with work primarily performed in office and quality system settings that support production activities. The position involves regular interaction with manufacturing areas, quality assurance functions, and cross-functional technical teams. You will work extensively in electronic quality management systems and documentation platforms to review and oversee deviations, CAPAs, and investigations. The environment emphasizes regulatory compliance, data integrity, and inspection readiness, with a strong focus on collaboration and continuous improvement to ensure products reach patients reliably and on time. Job Type & Location This is a Contract position based out of Rocky Mount, NC. Pay and Benefits The pay range for this position is $60.00 - $85.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Rocky Mount,NC.

Application Deadline This position is anticipated to close on May 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.