Job Description
Job DescriptionSalary: $65-75k
Job Summary
The Investigation Specialist is a key role within the Quality Assurance department, responsible
for leading and conducting thorough investigations of deviations, product complaints, and other
quality-related events that may occur in the Gifthealth pharmacy operation.
The Specialist drives root cause analysis and implements effective corrective and preventive
actions (CAPA) to uphold product quality, patient safety, and regulatory compliance.
Key Responsibilities
- Conduct comprehensive investigations related to deviations, supplier material
- non-conformances, and/or customer complaints.
- Develop, monitor, and follow up on CAPA plans to ensure timely resolution and
- prevention of recurrence.
- Support internal and external regulatory audits and inspections by preparing and
- presenting investigation-related documentation.
- Maintain accurate, complete, and audit-ready investigation records in electronic and/or
- paper systems.
- Contribute to continuous improvement initiatives for investigation processes and quality
- management systems.
- Train and mentor team members on investigation procedures and best practices.
- Act as Quality on the Floor to support the pharmacy operation and help to maintain a
- Right First Time quality culture.
- Manage monthly deviation tracking and trending.
- Develop SOPs related to Deviation, Complaint Investigation and CAPA Management.
Qualifications
- Bachelors degree in Pharmacy, Chemistry, Biology, or related Life Sciences field.
- Minimum of 3-5 years experience performing pharmaceutical and/or medical device
- GMP investigations.
- Proficient in root cause analysis, risk assessment, and CAPA management.
- Excellent written and verbal communication skills, with ability to document and present
- findings clearly.
- Strong analytical and problem-solving skills, with attention to detail.
- Ability to work independently and cross-functionally in a fast-paced environment.
- Experience working in a pharmaceutical manufacturing environment would be a bonus.