Job Overview:
Pay Range: $34.40hr - $39.40hr
Requirement/Must Have:
- BA/BS in Technical or Life Science field.
- 2-5 years of experience in the Pharmaceutical or related industry.
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP.
- Up-to-date knowledge of DEA regulations.
- Experience working in a quality organization.
- Demonstrated understanding of regulatory requirements that impact Market Quality.
- Experience in dealing with regulatory inspections and inspectional requirements.
Responsibilities:
- Support quality activities for Commercial Quality including controlled substance requirements, quality complaints, change control, documentation, and internal/supplier audits.
- Adhere to environmental policy and procedures and support department environmental objectives.
- Process Know Your Customer applications to purchase specific products.
- Conduct routine data analysis for Suspicious Order Monitoring.
- Process day-to-day product quality complaints (PQC) in the quality system, including evaluating PQCs, assigning investigations, conducting investigations, and writing investigation summaries.
- Proactively manage PQC workflows with stakeholders to ensure all investigations are completed in a timely manner.
- Process day-to-day quality events and change control records in the COMET system.
- Coordinate documents and procedures in the truVault system and other document management systems.
- Coordinate internal and/or supplier audits including setting up logistics, drafting audit plans, supporting audit execution, and coordinating audit responses and CAPAs with stakeholders.
- Ensure all audit commitments are delivered on time.
- Support Quality and Compliance Initiatives from Enterprise Quality and Global Business Quality.
Nice to Have:
- MA/MS/MBA in Business, Technical, or Life Science.
Skills:
- Highly experienced in COMET system.
- Proficiency in generating queries and reports.
- Data analysis with excel spreadsheets.
- Strong verbal and written communication skills.
- Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial, and Quality functional groups.
- Innovation and ability to master complexity.
- Customer and marketplace focus.
- Independent partnering.
Qualification And Education:
- Bachelors degree in Technical or Life Science field.
Benefits:
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.