Investigation Writer

Kelly Science, Engineering, Technology & Telecom; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking an Investigation Writer to support a global biopharmaceutical client in the Barceloneta, PR area. The role focuses on quality assurance investigations, CAPA coordination, and ensuring compliance with cGMP and Customer policies.

You will lead and participate in investigations across manufacturing, laboratories, and quality systems, document thoroughly, and drive timely corrective actions.

Qualifications

• Bachelor’s degree in science or engineering with 4+ years in quality/technical field in PHARMA/biotech.
• Advanced knowledge of GMP and safety regulations.
• Strong English and Spanish written/verbal communication.
• Experience in CAPA including authoring/approving investigations.
• Strong problem-solving skills.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring.
• Investigate events in manufacturing, labs, validation, or complaints areas.
• Ensure thorough investigation documentation and CAPA-based closure.
• Conduct complaint investigations ensuring policy/regulatory compliance.
• Lead or support laboratory investigations for out-of-spec results.
• Support plant users on Expectation Events IT Systems.
• Coordinate local change plans with end users and impacted areas.
• Produce periodic quality metrics on investigations and CPs.
• Provide New Product QA investigator writer support as needed.
• Assist during internal or external inspections.

Skills

Bilingual

QA Skills

Written English

Education

Bachelor’s degree

Biology/Chemistry

Job description

At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?

We’re seeking an Investigation Writer to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right

The Investigator writer is responsible for providing quality assurance support for the plant including resolution corrective and preventive action 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 Customer policy compliance for the manufacturing plant. Understands internal business process, to make appropriate prioritization of their assigned work duties.

Responsibilities:

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring systems, assuring they are in compliance with Customer Operations policies, plant procedures and regulations.
• Investigate activities when an exception event occurs in the manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability or complaints area.
• Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements.
• Perform complaint investigations when product quality complaints are received at the plant and assuring, they are in compliance with Customer Operations policies, plant procedures and regulatory requirements.
• Perform laboratory investigations when out of specification or trend results are reported in accordance with Customer procedures and policies.
• Provide support to the plant users on the Expectation Events IT Systems.
• Document and coordinate Local change plans assessment and strategies in support with the end user and functional impacted areas.
• Perform periodic quality metrics related to investigations, complaints, CP, PQRs and other key performance indicators from areas of responsibility as requested by area managements.
• Responsible of providing New Product support as a QA investigator writer as required by the New Product process and serve as a QA liaison between Customer, Ltd. and Third-Party Manufacturers or Third-Party Contractors.
• Responsible of providing support during internal or external inspections. Responsible for executing assigned tasks as required by the operational area. Could be assigned the responsibility of evaluating potential events, as first point of contact, in the manufacturing floor, to define immediate mitigation activities.

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.
• Advance knowledge and prior exposure in technical and operations necessary to successfully perform responsibilities of position. Knowledge of GMP, 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 other quality systems such as Complaints and Product Quality Reviews.
• Strong problem-solving skills.
• Fully Bilingual is a requirement / excellent English writing is a requirement.
• Customer complaint investigations.
• Manufacturing investigation is a priority.