This Pharmaceutical client has presence in more than 100 countries and offers a comprehensive, diverse and highly complementary portfolio including generic & specialty medicines targeting a wide spectrum of chronic & acute treatments.
They are looking for a Senior Quality Assurance Associate to support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
Senior Quality Assurance Associate Responsibilities:
- Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
- Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits. Facilitate review and support regulatory inspection management.
- Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
- Collaborate with Corporate compliance group and implement global CAPA.
- Support for major health authority inspections at site and provide input and support to inspection readiness/ responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
- Support compliance investigations as needed, in collaboration with others at the site.
- Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings
- Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
- Interface extensively on a daily basis with all departments.
- Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business
Senior Quality Assurance Associate Qualifications:
- B.S. in chemistry or related scientific field
- Minimum 6 - 8+ years related experience in a pharmaceutical manufacturing environment
- Working knowledge of cGMPs, GLPs
- Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
- Strong knowledge of instrumental and wet analytical chemistry
- Strong knowledge of microbiology testing
- Strong working knowledge of MS Office software
- Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc…
- Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
- Product Quality Complaints (PQC)
- Annual Product Quality Review (APQR/ APR)
- Quality Matrix
- Quality Review Board (QRB)/ Quality investigation Board (QIB)
- Internal audit/ Self inspection
Senior Quality Assurance Associate Benefits:
- Medical, Dental, Vision Benefits
- 3 weeks paid vacation, one personal day, 2 floating holidays, 10 paid vacation days
- Health Savings Account (HSA), Flexible Spending Account (FSA)
- Prescription Drug Coverage
- Telehealth and Behavior Health Services
- Income Protection - Short Term and Long Term Disability Benefits
- Retirement Benefits - 4% 401(k) Company Match on Day One (100% vesting immediately)
- Group Life Insurance
- Wellness Programs
- Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods