Job Details

Job Summary:

The Quality Engineer II independently leads standard deviation investigations related to manufacturing, packaging, material handling, and laboratory support activities. This role performs structured root cause analysis, develops and implements CAPAs, and ensures that investigation reports are complete, scientifically sound, and compliant. The Quality Engineer II acts as a technical resource for operations and supports continuous improvement of investigation and CAPA processes.

Duties and Responsibilities:
• Lead full lifecycle of routine and moderately complex deviation investigations.
• Perform thorough assessment of potential product impact, quality risks, and systemic implications.
• Conduct structured root cause analysis and document rationale for conclusions.
• Author clear, complete, and well-supported investigation reports suitable for internal and regulatory review.
• Identify, propose, and implement effective CAPAs tied directly to identified root causes.
• Collaborate with Manufacturing, Packaging, QC, and Facilities to validate findings and ensure implementation feasibility.
• Perform CAPA effectiveness checks and identify opportunities for prevention-based solutions.
• Contribute to trending reports and communicate findings to management.
• Support training and mentoring of junior QE staff or Specialists.
• Participate in inspection readiness activities and present investigations during audits.

Required Skills/Abilities:
• Strong technical problem-solving skills.
• Ability to synthesize data and clearly articulate investigation conclusions.
• Strong understanding of cGMP, documentation practices, and regulatory expectations.
• Effective facilitation and communication skills across multiple departments.

Education and Experience:
• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field required.
• 3-7 years of pharmaceutical or regulated manufacturing experience.
• Demonstrated experience conducting deviation investigations and performing root cause analysis.
• Experience using electronic quality systems (TrackWise strongly preferred).

Physical Requirements/ Working Conditions:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be provided to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use include reaching forward, grasping, finger and wrist manipulation, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands.

To perform this job successfully, an individual must be able to perform the essential jobfunctions satisfactorily. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products-including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances-is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.