Keystone Industries · 1 month ago
Quality Assurance Associate
Gibbstown, NJ
Full-time
Hybrid
New Grad, Entry Level
$55K/yr - $80K/yr
0+ years expKeystone Industries is dedicated to fostering a stimulating work environment for its employees. The Quality Assurance Associate will be responsible for overseeing quality system elements, performing audits, and assisting with quality documentation and training programs.
ManufacturingPackaging ServicesProduct Research
Responsibilities
Define/clarify cGMP and Quality Management requirements across all divisions and help coordinate Keystone's efforts for meeting them. Coordinate/revise/assist with the GMP/GDP training program and ISO Awareness program as needed
Oversee and coordinate quality system elements as assigned, including but not limited to the Internal Audit system, Customer Complaint Handling, Deviations, Non-Conformances and CAPA systems
Perform batch record reviews. Ensure proper follow-up and close-out of any issues and that appropriate documentation is completed and maintained
Perform Internal and support External (supplier) audits, when qualified
Assist the Quality Assurance Specialist and/or Manager in managing the Supplier Quality Management System
Assist with quality system documentation including but not limited to writing, revising and proof-reading Quality System Procedures, Keystone's Quality Manual, department or task instructions, SOP's, checklists, forms, etc
Prepare and maintain product technical documents, validation documents, change managements and other technical and quality system documents and records as necessary. Provide guidance to other personnel to ensure record requirements for project planning, design control, purchasing activities, customer complaints and other feedback, etc. are met
Assist with Management Reviews of the Quality System. Review and summarize trend analysis data as requested such as customer complaints, product, and system non-conformances, returns and credit data, CAR/PARs, etc. Help prepare Management Review Reports, assist with data presentation and ensure appropriate meeting minutes are recorded, and follow-up activities are performed and documented
Assist with project planning, design control and risk assessment responsibilities as necessary
Inform the Senior Quality, Regulatory and/or Executive Management team members of problems found within the quality system and updates on improvements or necessary corrective actions
Assist with external regulatory, customer and ISO Notified Body audits. Help coordinate/document resulting corrective action closeout activities
Handle customer communication as necessary
Perform additional duties/tasks as needed or requested by management
Qualification
Required
0-3 years of Quality Assurance and ISO Quality System experience
General knowledge of Quality System Elements (FDA CFRs, ISO standards, Complaint Handling, CAPA, Deviation, Change Management, Document Control, etc.)
Exceptional computer skills (Microsoft Office)
Exceptional interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally
Strong writing skills
Ability to successfully work on multiple job tasks/projects simultaneously
Project management and organizational skills
Time management skills and deadline driven
High attention to detail
Bachelor's degree in a technical field (chemistry, biology, biochemistry, or similar); will consider non-degreed relevant work experience in quality, regulatory, or related field
Preferred
Knowledge of FDA cGMP for medical devices and Pharmaceutical
Understanding of current ISO 13485 and supporting ISO standard requirements
Knowledge of system auditing techniques and requirements
ISO Quality System Training
Internal Auditor Training
Benefits
Weekly Pay
Comprehensive Health Coverage - Medical, Dental & Vision Plans
Flexible Spending Accounts (FSA) – Medical & Dependent Care or Health Savings Account (HSA) Options
Company-Paid Life Insurance + Additional Voluntary Options
401(k) Retirement Plan with 3% Employer Contribution (after 1 year)
Fitness Benefits - Onsite Gym (Headquarters) or Membership Reimbursement (other sites)
Paid Time Off & Holidays to support work-life balance
Employee Assistance Program (EAP) for confidential support
Financial Wellness Resources
Employee Discounts & Perks (Eagles games, concert tickets, etc.)
Company Social Events & Team Activities
Career Development Opportunities & Internal Growth
Company
Keystone Industries
Keystone Industries is a manufacturer of dental and cosmetic products.
201-500 employees
H1B Sponsorship
Keystone Industries 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
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Irina Rapoport, CPA, CGMA
Chief Financial Officer
Recent News
2026-01-06
GlobeNewswire News Room
2025-07-14
Company data provided by crunchbase