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Quality Assurance and Pharmacovigilance Associate I
2 months ago
Position Overview:
This role is a hybrid opportunity, requiring full onsite presence during the initial training phase, followed by a schedule of three days in the office and two days working remotely.
The individual will be an integral part of Collins Consulting's global quality team, responsible for managing complaints and inquiries related to pharmaceutical products, medical devices, and combination products.
Key Responsibilities:
- Ensure that all complaint records comply with global standards.
- Document and investigate product complaints, focusing on non-medical issues while also reviewing medical complaints related to quality concerns.
- Deliver exceptional customer service by coordinating the return of samples for investigation and managing follow-up actions, including product replacements.
- Maintain compliance with Good Documentation Practices, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP). This role demands strong analytical skills, technical writing abilities, and meticulous documentation.
- Identify potentially reportable events and communicate these to relevant functional teams and management.
- Collaborate with third-party manufacturers, healthcare professionals, and various internal departments, as well as regulatory bodies.
Qualifications:
- Familiarity with global regulatory standards for pharmaceuticals, medical devices, and combination products.
- Understanding of FDA regulations concerning Quality Systems and Medical Device Reporting (21 CFR 803, 820, and 211) is advantageous.
- Ability to manage multiple projects while ensuring adherence to regulations and standard operating procedures.
- Strong written and verbal communication skills, along with excellent organizational capabilities.
- Proficiency in computer systems for documentation and complaint management.
- Experience working collaboratively with cross-functional teams and effectively engaging with peers, management, and clients.
- A Bachelor’s degree is required, preferably in a scientific or technical field (e.g., MLT, LPN, RN).
- 0-3 years of experience in a cGMP environment or clinical setting is preferred, with at least one year of experience in quality assurance or complaint management.
Preferred Skills:
- Attention to detail
- Proficiency in Microsoft Excel, including sorting and filtering capabilities
- Adaptability to change
- Self-motivated and capable of working independently
- Initiative in improving processes and enhancing efficiency
Additional Considerations:
- A degree in a relevant field is preferred.
- 3-5 years of experience in quality assurance or complaint management is a plus.
