Vertex · 7 hours ago
GMP Operational Quality Senior Specialist (QA Ops for QC)
Boston, MA
Full-time
Onsite
Mid, Senior Level
$94K/yr - $141K/yr
2+ years expVertex is a global biotechnology company that invests in scientific innovation, and they are seeking a GMP Operational Quality Senior Specialist. This role supports quality assurance and regulatory compliance, providing QA support for manufacturing operations and analytical laboratory operations while reviewing batch data and ensuring documentation is acceptable for product disposition.
Computer Software
Responsibilities
Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Supports change control assessments, implementation and closure
Identifies and facilitates continuous improvement efforts
Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills
Support continuous improvement projects
Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures
Ensures presence and acceptability of all required documentation prior approval of data
Support the day-to-day management of the batch release process
Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed
Communicates proactively with internal and external partners and management
Maintains files such that documents are readily available and easily retrievable
Assists department with monthly/quarterly Quality System data review metrics and reporting
Escalate critical and major findings to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GxP operational areas
Qualification
Required
Bachelor's degree in scientific or allied health field (or equivalent degree)
Typically requires 2+ years of experience, or the equivalent combination of education and experience
Strong communication and influencing skills
Critical Thinking/Problem Solving
Ability to evaluate quality matters and make decisions utilizing risk-based approach
Proficiency in using Microsoft Office applications
Some experience with Cell and/or Gene Therapy QA experience, working knowledge of aseptic processing and quality metrics, dashboards, analysis and improvement programs
Some experience providing QA support and oversight of GMP manufacturing operation
Some experience successfully participating in event investigations, Root Cause Analysis and CAPA
Some experience with network-based applications such as Oracle, TrackWise, Veeva
Basic knowledge of current industry trends and has the ability to use the latest technologies
Preferred
Experience supporting multiple projects/teams within stated objectives and timelines
Experience supporting cross-functional team members and collaborate effectively
Good communication skills (written and verbal) and the ability to exchange potentially complex information
Able to integrates activities with other groups, departments and project teams as needed
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
Benefits
Annual bonus
Annual equity awards
Overtime pay
Medical, dental and vision benefits
Generous paid time off
Educational assistance programs including student loan repayment
Generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex 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
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase