Address
Form of work
SalaryDescription:
- Perform and manage the intake, triage, and investigation of product complaints, documenting these activities in the electronic Quality Events system
- Lead cross-functional product complaint investigations with client and contract manufacturing organizations
- Communicate with the complainant (e.g., patient, health care provider) to procure information in support of product complaint investigations
- Maintain and monitor the product complaint mailbox to ensure all cases are responded to and escalate critical events to the Head of Quality and QP
- Forward product complaints to Drug Safety that are also associated with adverse events/safety information
- Perform monthly reconciliation of product complaints and adverse events/safety information with Global Medical Safety/Drug Safety to ensure all cases have been properly reported
- Provide support for audit/inspection activities in matters related to product complaints, quality investigations, and CAPA
- Maintain product complaint tracker and provide Sr Management periodic status updates
- Prepare and maintain accurate product complaint metrics for Management Review
- Support the development, implementation, and continuous improvement of product complaint procedures (SOPs/WIs/guidelines)
- Provide product complaint training to employees and vendors, and periodically assess and revise the training material to ensure its effectiveness
Top Skills' Details:
- Biologics
- Drug Substance
- Complaint Handling
- Investigations
Additional Skills & Qualifications:
- BS in Biology or Chemistry with 3+ years' experience
- Understand GMP regulations and 21 CFR 210 and 211, ICH, and FDA guidance
Schedule:
Hybrid on site 4 days a week, WFH on Fridays!
Job Type: Full-time
Pay: $55.00 - $60.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Lexington, MA 02421: Relocate before starting work (Required)
Work Location: In person
