MR01-041426 Investigation Writer III

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Investigation Writer III

Description:

The Investigator Writer is responsible for providing quality assurance support for the plant including resolution, corrective and preventive action (CAPA) for events, leading and participating in investigations, coordination and leading of local Change Plan, support in complaint investigations, quality improvement programs, and assurance of cGMP and company policy compliance for the manufacturing plant. Understands internal business processes to make appropriate prioritization of assigned work duties.

Key Responsibilities:

• Perform exception reports, complaints, PQRs, Change Plan coordination and trend monitoring systems, assuring compliance with company policies, plant procedures and regulations.
• Investigate activities when an exception event occurs in manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability or complaints area.
• Responsible for consistent and thorough exception events investigation, documentation and timely resolution based on CAPA requirements.
• Perform complaint investigations ensuring compliance with policies, procedures and regulatory requirements.
• Perform laboratory investigations when out of specification or trend results are reported.
• Provide support to plant users on Exception Events IT Systems.
• Document and coordinate Local Change Plans assessment and strategies with end users and impacted functional areas.
• Perform periodic quality metrics related to investigations, complaints, Change Plans, PQRs and key performance indicators.
• Provide New Product support as QA investigator writer and serve as liaison between company and third-party manufacturers or contractors.
• Provide support during internal or external inspections.
• Evaluate potential events as first point of contact on the manufacturing floor and define immediate mitigation actions.
• Ensure compliance with EHS management systems, including incident reporting, PPE use, waste management and applicable programs.

Investigation & CAPA Responsibilities:

• Perform investigation activities for exception events across manufacturing, laboratory, validation, microbiology, stability, or complaints areas.
• Monitor and drive continuous improvement of the CAPA quality system.
• Compile information and write exception documents for approvals.
• Ensure investigations comply with policies, procedures and regulatory requirements.
• Manage investigation processes to determine root cause.
• Assess product impact and provide accurate recommendations.
• Define corrective and preventive actions to prevent recurrence.
• Ensure timely approval of investigation reports.
• Ensure CAPAs are implemented and assess their effectiveness.

Complaint & PQR Responsibilities:

• Perform complaint investigations ensuring timely execution and protection of company and customer interests.
• Implement CAPAs derived from complaint investigations.
• Maintain Product Quality Review (PQR) system in compliance with regulatory requirements.
• Generate PQRs for each product and ensure compliance.
• Prepare and approve PQR schedules.
• Perform statistical analysis and generate trend reports.
• Evaluate product performance based on collected data.
• Identify adverse trends and support continuous improvement

Qualifications:

• Bachelor’s Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of four (4) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry.
• Master’s Degree in Science or Engineering, preferably Biology or Chemistry with a minimum of two (2) years of experience in a Quality or technical field within the Pharmaceutical or Biotechnological industry.
• Advanced knowledge in technical and operations areas. Knowledge of GMP and safety regulations.
• Effective verbal and written communication skills in both English and Spanish.
• Prior experience in CAPA, including authoring and approval of laboratory and manufacturing investigations.
• Experience in quality systems such as Change Management and Risk Management documentation.
• Strong interpersonal, communication and problem-solving skills.
• Capable of handling multiple priorities
• Strong knowledge (according to related area).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.