Job description

ProQuality Network is a pharmaceutical consulting firm of industry leaders that provides quality services to the Life Sciences industries.

We are currently seeking a Specialist Quality Complaints Investigators to provide services on site in Pharma/Biotech Industry. This position is based in Puerto Rico.

Job Duties:

• Experience in the Pharmaceutical/Biotech Industry with main roles in Manufacturing/Packaging deviations, Root Cause Analysis, Complaint Investigations, Project Management and Compliance.
• Support the product complaint system, leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
• Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
• Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
• Follow-up on corrective actions derived from investigations through completion.
• Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
• On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
• Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.

Candidates must be able to work on-site.

Knowledge/Skills:

• Bachelor’s degree in Science.
• 5 years of directly experience in Pharma/Biotech Industry.
• Must be able to read, write, and speak fluent SPANISH AND ENGLISH.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines.
• Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
• Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines.
• Must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Strong interpersonal skills with ability to collaborate with outside resources in a professional manner.
• Ability to evaluate issus, make decisions and determine when to escalate, as necessary.
• Computer literacy, independently understand, follow and implement instructions.

Job Types: Full-time, Contract, Temporary

Weekly day range:

• Monday to Friday
• Weekend availability

COVID-19 considerations:
Candidates must comply with site COVID precautions, which may change over time depending on federal, state, and company guidelines and recommendations.

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical industry: 5 years (Required)

Language:

• Spanish (Required)
• English (Required)

Work Location: One location

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