Product Quality Assurance Specialist

4 weeks ago

Windsor, Ontario, Canada ProPharma Group Full time

For over two decades, ProPharma has been dedicated to enhancing patient health and wellness by offering expert guidance that empowers organizations in biotechnology, medical devices, and pharmaceuticals to confidently progress scientific innovations and launch new treatments. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate model throughout the entire product lifecycle. With extensive expertise in regulatory affairs, clinical research, quality assurance, pharmacovigilance, medical information, and R&D technology, ProPharma provides a complete suite of customizable consulting solutions designed to mitigate risks and expedite our partners' most significant drug and device initiatives.

The role of the Product Complaint Specialist is essential in assessing product complaint cases generated by Medical Information for subsequent actions. This specialist may oversee product retrievals, conduct follow-up communications regarding product complaints, generate related correspondence, and fulfill additional product complaint services for designated clients. The Product Complaint Specialist may also be responsible for preparing and reviewing reconciliation reports as required by clients. This position demands a candidate with exceptional technical skills in proofreading and the ability to manage various processes and timelines within a regulated setting.

Key Responsibilities Include:
* Review product complaint cases to determine necessary next steps (if applicable):
* Coordinate retrieval processes for select client organizations, if applicable
* Conduct outbound follow-up calls to finalize Product Complaint reports and gather additional information as requested by clients.
* Draft letters in response to Product Complaints as instructed by clients.
* Provide additional contracted product complaint services for select client organizations.
* Enter electronic correspondence into case management systems.
* Generate and analyze reconciliation reports as necessary.
* Identify and report any new or follow-up Adverse Event details to the appropriate contacts.
* Recognize and report any new or follow-up Product Complaint details to the relevant parties.
* Offer administrative support for Medical Information as required.
* Manage the Product Complaint inbox.
* Update existing Product Complaint cases as needed.
* Handle inbound calls and check voicemails for the Product Complaint line.
* Perform other duties as assigned.

Qualified candidates should possess:
* A background as a Pharmacy Technician, Veterinary Technician, Life Science Graduate, or other relevant healthcare qualifications preferred.
* A high school diploma.
* Strong English language skills, particularly in verbal and written communication (including proofreading).
* Proficiency in writing fluent and grammatically correct American English.
* Familiarity with medical terminology, regulations, and industry standards.
* Excellent interpersonal skills, including empathetic customer service abilities.
* Accurate and efficient data entry skills.
* Capability to manage multiple tasks with attention to detail within tight deadlines.
* A proactive approach with the ability to independently identify issues and propose effective solutions.
* Strong organizational and prioritization skills in a rapidly changing environment with limited resources.
* Willingness to take direction and learn.
* Openness to constructive feedback.
* Self-motivation and initiative to seek additional workload projects.
* Ability to work effectively both independently and as part of a team.
* High proficiency in computer applications, including Microsoft Office and Adobe Acrobat, with experience in document management systems. An aptitude for learning other computer systems, including inquiry handling databases.

We celebrate our differences and strive to create a workplace where each individual can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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