CAPA Process Analyst II

Responsibilities

• Lead the investigation of complex and highly technical quality issues, ensuring the timely completion of CAPA system activities to address nonconformances, potential nonconformances, deviations, and complaints.
• Execute investigations and CAPAs in accordance with established procedures, ensuring consistency with quality system requirements.
• Serve as a subject matter expert in conducting investigations and performing root cause analysis to appropriately identify and mitigate/eliminate root and potential causes.
• Collaborate with laboratory operations and technical staff to conduct investigations and ensure corrective actions are appropriate and effectively implemented.
• Maintain CAPA system records to ensure audit-readiness for internal and external quality system audits.
• Ensure CAPA documentation is accurate, well-structured, and compliant with procedural requirements and regulatory guidelines.
• Support the initiation and implementation of improvement activities associated with identified trends.
• Escalate potential compliance risks, quality concerns, or procedural gaps to the Quality Manager for timely evaluation and resolution.
• Demonstrate effective written and verbal communication skills.
• Prioritize workload in relation to business needs.
• Support the attainment of company goals and objectives.

Requirements

• Bachelor's degree in Life Sciences.
• Experience with Corrective and Preventative Action process in regulated environments such as pharmaceuticals, medical devices, or laboratories.
• Excellent communication and technical writing skills.
• Experience in working with QMS platforms.

Additional Skills & Qualifications

• ASQ Certified Quality Auditor (CQA).
• Project management experience.
• Knowledge of College of American Pathologists (CAP) regulations, NLCP regulations, or similar regulations such as FDA.
• Experience with EQMS.

Work Environment

This position operates in a professional office environment with standard office hours from Monday to Friday, 8 AM to 5 PM. The role involves interacting cross-functionally, ensuring communication and business behaviors are consistent with company standards.

Job Type & Location

This is a Contract position based out of Gretna, LA.

Pay And Benefits

The pay range for this position is $33.00 - $33.00/hr.

Requirements

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)

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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.

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.