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Über
We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!
In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.
Position Details: Title:
Quality Assurance Associate Schedule:
8:00 am - 4:30 pm, M-F, with some flexibility. Location:
Gibbstown, NJ (08027) with requirements to work at another office in Cherry Hill, NJ weekly. Salary Range:
$55,000 - $80,000 annually, based on experience and qualifications. Essential Job Functions:
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. Qualifications:
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. Desired Skills:
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. Education/Certifications:
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. Safety:
Comply with all safety regulations; maintains a safe work environment at all times. Adhere to always wearing the proper PPE/Safety equipment. Understand and comply with all written safety, health, and environmental procedures. Attend all required scheduled Health, Safety and Environmental training sessions. Participate in required Health, Safety and Environmental initiatives and programs. Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets. Physical Demands and Work Environment :
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Physical Demands:
Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms to operate a computer and other office equipment, and occasionally lift/move up to 25 lbs. Minimal need to balance, stoop, bend, kneel or climb. Work Environment:
This position is located in an office setting, within a manufacturing facility. Noise intensity level: quiet to low. Employees may occasionally need to enter manufacturing or lab areas, including cleanroom environments, which may include exposure to moderate noise, moving equipment, and hazardous contaminants. When entering these areas, employees must adhere to all applicable safety protocols, including Personal Protective Equipment (PPE) and/or gowning requirements. Occasional travel may be required for audits, inspections, site visits, customer meetings or events, and industry conferences. Benefits and Perks:
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
Staffing Agency/Third-Party Recruiter Policy:
Keystone Industries partners only with approved recruiting agencies that have a current, signed agreement with our Human Resources department. Agencies may submit candidates
only
for positions they have been specifically requested to support by a Keystone recruiter. Unsolicited resumes or outreach that does not follow this process (including direct contact with hiring managers) will not be considered.
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Sprachkenntnisse
- English
Hinweis für Nutzer
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