Investigation Writer III
Weil Group, Inc, Barceloneta, Barceloneta, United States
The Senior 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 plans, support in complaint investigations, quality improvement programs, and assurance of cGMP and Client policy compliance for the manufacturing plant. Understands internal business processes to prioritise their assigned work duties.
Responsibilities
Perform exception reports, complaints, PQRs, CAPA coordination and trend monitoring systems, ensuring compliance with Client Operations policies, plant procedures and regulations.
Investigate activities when an exception event occurs in manufacturing, incoming laboratory, quality control laboratory, validation, microbiology, stability or complaints areas.
Document and resolve exception events in accordance with CAPA requirements.
Conduct laboratory investigations for out‑of‑specification or trend results as per Client procedures.
Provide support to plant users on Event IT Systems.
Document and coordinate local change plan assessment and strategies with end‑users and impacted areas.
Perform periodic quality metrics for investigations, complaints, CAPA, PQRs and other KPIs as requested by area management.
Act as a QA liaison during new product support and serve as a QA investigator writer as required by the new product process.
Support internal or external inspections and execute assigned tasks as required by the operational area.
Serve as the first point of contact to evaluate potential events on the manufacturing floor and define immediate mitigation activities.
Conform to EHS management system requirements; promote continuous improvement and consider EHS aspects during design and change processes.
Qualifications
Bachelor’s Degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of 4 years 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 2 years experience in a quality or technical field within the pharmaceutical or biotechnological industry.
Advance knowledge and prior exposure in technical operations necessary to perform the responsibilities of this position.
Knowledge of GMP, safety regulations and quality systems (e.g., CAPA, change management, risk management).
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 interpersonal and communication skills.
Strong problem‑solving skills.
Ability to handle multiple priorities.
At least 5–7 years of experience in pharmaceutical operations, preferably solid dose manufacturing.
Key Skills and Experience
Bachelor’s Degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of four years experience in a quality or technical field within the pharmaceutical or biotechnological industry.
Advanced knowledge and exposure in technical operations; understanding 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.
Strong problem‑solving skills.
Nice to Have
Certification in root cause analysis for pharmaceutical processes.
Weil Group is proud to be an Equal Employment Opportunity Employer.
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Responsibilities
Perform exception reports, complaints, PQRs, CAPA coordination and trend monitoring systems, ensuring compliance with Client Operations policies, plant procedures and regulations.
Investigate activities when an exception event occurs in manufacturing, incoming laboratory, quality control laboratory, validation, microbiology, stability or complaints areas.
Document and resolve exception events in accordance with CAPA requirements.
Conduct laboratory investigations for out‑of‑specification or trend results as per Client procedures.
Provide support to plant users on Event IT Systems.
Document and coordinate local change plan assessment and strategies with end‑users and impacted areas.
Perform periodic quality metrics for investigations, complaints, CAPA, PQRs and other KPIs as requested by area management.
Act as a QA liaison during new product support and serve as a QA investigator writer as required by the new product process.
Support internal or external inspections and execute assigned tasks as required by the operational area.
Serve as the first point of contact to evaluate potential events on the manufacturing floor and define immediate mitigation activities.
Conform to EHS management system requirements; promote continuous improvement and consider EHS aspects during design and change processes.
Qualifications
Bachelor’s Degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of 4 years 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 2 years experience in a quality or technical field within the pharmaceutical or biotechnological industry.
Advance knowledge and prior exposure in technical operations necessary to perform the responsibilities of this position.
Knowledge of GMP, safety regulations and quality systems (e.g., CAPA, change management, risk management).
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 interpersonal and communication skills.
Strong problem‑solving skills.
Ability to handle multiple priorities.
At least 5–7 years of experience in pharmaceutical operations, preferably solid dose manufacturing.
Key Skills and Experience
Bachelor’s Degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of four years experience in a quality or technical field within the pharmaceutical or biotechnological industry.
Advanced knowledge and exposure in technical operations; understanding 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.
Strong problem‑solving skills.
Nice to Have
Certification in root cause analysis for pharmaceutical processes.
Weil Group is proud to be an Equal Employment Opportunity Employer.
#J-18808-Ljbffr