ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition.

REQUIREMENTS

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including batch release
• Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting.
• Cell and gene therapy cGMP’s and associated CMC regulatory considerations
• Experience with Aseptic processing
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise
• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.

ROLE WILL START OFF M-F FOR TRAINING (2 WEEKS). AFTER THE CANDIDATE IS TRAINED - THE ROLE WILL MOVE TO 4-10 HOUR SHIFTS:

• Wed-Sat 12:30pm est. - 11:00pm est.
• Sun-Wed 12:30pm est. – 11:00pm est.

KEY RESPONSIBILITIES:

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Client operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operations
• Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Responsible for review and approval of COAs, and product release
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
• Provides experienced technical advice for fill finish related program decisions
• Provides project support involving technical transfers, engineering projects and similar activities
• Participate in compliance walkthroughs and help drive the closure of any observations
• 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.
• Participate in inspection readiness and support activities
• Participate in process improvement initiatives (as necessary).
• Experience on product complaints investigations and recalls