CAPA Technical Writer - Investigations

Primary Talent Partners has a new 12 month contract Investigations CAPA Writer opening with a biotech healthcare client operating out of Round Lake, IL.

Please note: Potential for contract renewal or direct-hire opportunities are dependent upon performance and company budget.
Pay: $48.00 to $53.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.
Schedule: Mon - Fri standard business hours; 40-hour work week

Description:

We are seeking highly motivated and detail-oriented CAPA/Client Writers to join our quality and compliance team. The ideal candidate will be responsible for conducting investigations and implementing corrective and preventive actions (CAPAs) within a cGMP-regulated environment. This role requires strong problem-solving skills, regulatory knowledge, and the ability to work both independently and collaboratively to maintain a culture of compliance and continuous improvement.

Key Responsibilities:

• Perform non-conformance investigations (Client) using the TrackWise 8 Management System.
• Execute CAPA implementation in alignment with investigation findings.
• Maintain up-to-date knowledge of regulatory requirements; ensure compliance with local procedures and global corporate quality standards.
• Provide coaching and support for DMAIC problem-solving and process improvement projects.
• Help maintain audit readiness and assist other departments in meeting compliance standards.

Qualifications:

• Must not be allergic to Penicillins or Cephalosporins.
• Strong understanding of manufacturing processes and product usage.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent problem-solving, analytical, and decision-making abilities.
• Skilled in consultation, facilitation, and team collaboration.
• Proficiency in statistics to support data-driven decision-making.
• Strong written and verbal communication skills.
• Capable of working with minimal supervision.
• Customer-oriented with the ability to interact across all organizational levels.
• Experience with TrackWise (preferred).
• Knowledge of FDA and International Regulatory requirements.
• Familiarity with risk management tools.
• Flexibility to work off-shifts or weekends when necessary to support investigations or training.

Education & Experience:

• Bachelor’s degree in Science, Engineering, or a related field (required).
• 2-4 years of relevant experience in a cGMP-regulated industry or clinical setting.
   

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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