inSync Staffing · 3 days ago
Quality Assurance Specialist
Philadelphia, PA
Contract
Onsite
Mid Level
$40/hr - $43.48/hr
3+ years expinSync Staffing is seeking a Quality Assurance Specialist to provide quality oversight and technical support for manufacturing activities at Roche’s Spark location in Philadelphia. The role involves reviewing batch records, managing deviations, and ensuring compliance with cGMP and quality system requirements in a regulated pharmaceutical environment.
B2BDeliveryHuman ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Becca Kamarad
Responsibilities
Provide quality, technical support and oversight during manufacturing activities under general supervision
Review executed batch records and evaluate product and facility deviations; support product disposition decisions
Open deviations as appropriate and ensure documentation is completed and closed prior to material or lot release
Review and evaluate QC testing records and associated OOS investigations
Review, write, revise, and approve SOPs, technical documents, and reports
Perform inspection and release of materials used for production, including review of vendor certificates for compliance
Compile and maintain quality metrics and evaluate trends to identify irregularities
Provide administrative project management support for Quality Management System integration and improvement initiatives
Support Quality Risk Management governance, including documentation, risk registers, and CAPA plans
Support coordination of site Change Control Review Board and related communications
Prepare Certificates of Compliance (CoC) and Certificates of Analysis (CoA) for clinical and commercial materials
Perform additional responsibilities as assigned by the QA Operations Lead
Qualification
Required
Bachelor's degree in a scientific discipline
Minimum of 3–5 years' experience in a regulated manufacturing environment with exposure to Quality and Manufacturing
Knowledge of Quality Systems including Change Control, Investigations, and CAPA
General working knowledge of cGMP regulations and guidelines
Technical writing experience related to investigations and quality documentation
Strong attention to detail and ability to manage multiple priorities
Effective written and verbal communication skills
Proficiency with computer systems and documentation tools
Ability to work effectively in a team environment and with external partners
Ability to analyze data, define problems, draw conclusions, and exercise sound judgment
Ability to support creation and organization of cGMP system procedures with guidance from senior team members
Preferred
Pharmaceutical background preferred
Benefits
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
Company
inSync Staffing
inSync Staffing is a staffing and recruiting company providing staff augmentation services.
501-1000 employees
H1B Sponsorship
inSync Staffing 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
2024 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase