Atrium · 1 month ago
2nd Shift -Quality Assurance Senior Specialist (Contract) 27517
US-MA-Boston
Full-time, Contract
Onsite
Mid, Senior Level
$55/hr - $65/hr
3+ years expAtrium is a staffing agency seeking a 2nd Shift Quality Assurance Senior Specialist for Vertex Pharmaceuticals. The role involves providing quality oversight and support for GMP operations, particularly in drug product disposition and compliance, while leading cross-functional teams to ensure adherence to quality standards.
Real Estate
Responsibilities
As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy 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
Review and approval of manufacturing documents
Develop and deliver technical training programs
Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
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 continuous improvements of department processes
Participate in inspection readiness and support activities
Participate in process improvement initiatives (as necessary)
Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
Experience on product complaints investigations and recalls
Qualification
Required
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
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
Strong leadership skills with the ability to thrive in a high throughput environment
Ability to independently lead cross-functional teams and represent the Quality unit
Ability to communicate effectively across all organizational levels
Ability to evaluate quality matters and make decisions utilizing risk-based approach
Attention to detail
Expert knowledge of GMP requirements governing oral drug products manufacturing practices
Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP manufacturing
Benefits
Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
This role will be eligible for overtime pay, in accordance with federal and state requirements
Company
Atrium
Atrium is a global WBENC-certified Talent Solutions and Extended Workforce Management leader.
201-500 employees
H1B Sponsorship
Atrium has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Caylon Joiner
Talent Acquisition Partner
Shannon Mooney
Managing Director, Strategic Partnerships
Company data provided by crunchbase