Ou client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, our client has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
TITLE/ROLE: Quality Specialist (Contract) – QA Operations & Compliance AREA: CMC and Patient Safety QA
GENERAL POSITION SUMMARY:
The Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. The Quality Specialist demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices ensuring alignment with all regulatory requirements.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES Key Leadership Skills:
• Cross- functional collaborator
• Results Driver
Key Knowledge/ Skills and Competencies:
o Ability to perform functions in accordance with cGMP guidelines.
o Strong written and oral communication skills required
o Good interpersonal skills required
o Ability to work effectively and meet challenging timelines in a fast –paced and high throughput environment
o Strong organizational skills, work ethics and respect for all customers.
o Collaboration / Teamwork / Conflict Management
o Ability to independently coordinate with cross-functional teams
o Critical Thinking
o Ability to think strategically and tactically, balancing these as workload changes.
o Should be flexible to work 2nd shift as per the business needs
o Attention to detail
o Knowledge in the following areas:
o Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral
drug product manufacturing practices
o Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role
• As part of the Quality Operations and Compliance group primarily responsible with providing quality oversight and support to operations at the Vertex Drug Product Facility (VMC) in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.
Product Release – Internal Manufacturing
• Responsible for reviewing batch data, including batch records, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
• Responsible for archival of batch records and other supporting documents in QDoCCs.
Compliance Oversight of Internal Operations – QA Operations and Compliance
• Responsible for raw material release and labelling
• Responsible for CNC area clearance and equipment release to support manufacturing operations.
Compliance Oversight of Quality Systems
• Responsible for updating QA database based on the ongoing / upcoming clinical and commercial manufacturing.
• Responsible for generating performance metrics, trends; including site metrics for investigation/CAPA, etc. (as applicable)
• Responsible for identifying risks and communicating gaps for GMP process/systems.
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Audit / Inspection Support
• Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary).
REQUIRED EDUCATION AND EXPERIENCE:
• Demonstrated success by independently collaborating with cross-functional teams
• Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
o cGMP’s and associated CMC regulatory considerations
o experience with continuous manufacturing a plus
• Experience with network based applications such as Oracle and TrackWise preferred.
• B.S in scientific or allied health field (or equivalent degree) with at least 5 years of relevant work experience