Quality Analyst

We are looking for Quality Analyst for our client in Titusville, NJ

Job Title: Quality Analyst

Job Location: Titusville, NJ

Job Type: Contract

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.

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• 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