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
Purpose:
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.
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.
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.
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Requirements
1. Bachelors 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. 
2. Advance knowledge and prior exposure in technical and operations necessary to successfully perform responsibilities of position. Knowledge of GMP, safety regulations. 
3. Effective verbal and written communication skills in both English and Spanish. 
4. 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. 
5. Strong problem-solving skills. 
6. Fully Bilingual is a requirement / excellent English writing is a requirement 
7. Customer complaint investigations 
8. Manufacturing investigation is a priority
 

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