Katalyst CRO · 3 hours ago
Quality Assurance Specialist
Philadelphia, PA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on providing quality assurance in the manufacturing sector. They are seeking a Quality Assurance Specialist to provide oversight during manufacturing activities, review documentation, and ensure compliance with quality standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Performs work under general supervision
Provide quality, technical support and oversight during manufacturing activities
Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark
Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition
Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release
Review and evaluate QC testing records and any associated OOS investigations
Review, write, revise, and approve SOP's, technical documents, and reports
Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production
Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required
Provide administrative project management support for Quality Management System integration and improvement projects
Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc
Support coordination of site Change Control Review Board and change control communications with third party license holder
Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials
Other assigned responsibilities as established by the QA Operations Lead
Ability to work and communicate with contract manufacturers and testing organizations
Ability to define problems, collect data, establish facts, and draw valid conclusions
Analysis and problem-solving skills, including but not limited to the ability to review and analyze manufacturing, quality control and validation data
Ability to participate on cross-functional teams in root cause analysis and solution identification
Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPA's, and identifying requirements to implement changes in a controlled GMP environment
Qualification
Required
Bachelor's Degree in scientific discipline
Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field
Knowledge of Quality Systems such as Change Control, Investigations and CAPA
Ability to communicate effectively with wide range of personnel
Technical writing skills related to investigation reports
General working knowledge of relevant governmental regulations, cGMP and guidelines
Works under general supervision
Strong attention to detail
Ability to manage multiple priorities and tasks in a dynamic environment
Proficiency with computer programs
Ability to work effectively in a team environment
Ability to establish facts, define problems, collect data and draw valid conclusions
Ability to exercise judgment to determine appropriate corrective actions
With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations
Excellent written and verbal skills
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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