Pharmaceutical- Administrative and/or coordinator – PQC Technician – 21-02267 – Evergreen Technologies, LLC. – Kenilworth, NJ

We are seeking a PQC Technician for a 11-month project. We are looking for a collaborative team player who employs innovative thinking and enjoys a fast – paced ecommerce atmosphere. This PQC Technician exhibits strong communication skills, is familiar with various analytic tools, and excels at problem solving.

Responsibilities:

• Prioritizes complaints for data entry and processing.
• Understands the importance of data entry of complaints within the required timeframe.
• Understands special details for handling each product within the department.
• Understands departmental process flow on drug and device complaints.
• Proficient with use of all databases within the department (ie. ACES-Siebel, Global PTC Database, Microsoft Office).
• Prepares appropriate correspondence for complaints.
• Identifies and prepares appropriate mailers for use in retrieving the complaint samples.
• Produces daily reports for follow-up activity.
• Reviews and processes reconciliation with Pharmacovigilance.
• Process complaint samples upon receipt
• Identifies and handles lot discrepancies correctly with returned complaint samples.
• Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
• Identifies and prepares complaint samples for shipping to manufacturing sites.
• Orders departmental supplies.Identifies complaints for field alert reporting
• Performs QC Checks
• Provide customer service to consumers, health care professionals, and internal/external departments regarding individual complaints
• Provide support to US Product Quality Complaint Managers/Director during audits by FDA, other regulatory agencies, third parties and internal groups.Notifies interested departments (including manufacturing sites QA, commercial, regulatory, supply chain) upon receipt of complaints.
• Understands the FDA complaints regulations for the drug products and medical devices.
• Maintains monthly reports as neededProvide complaints support to other company departments including but not limited to customer service, medical information, Pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management
• Maintains sample room and mailroom as per departmental SOP.

Minimum qualifications:

• Bachelor’s degree in a science discipline preferred.
• Associate degree from an accredited two-year college or technical school
• Area of specialization: Health or Life Sciences preferred

Knowledge, Skills and Equivalent Experience:

• Associate degree with minimum 2-3 years of experience in a pharmaceutical, administrative, and/or coordinator environment or bachelor’s degree (science discipline preferred) + 2-3 years of experience in a pharmaceutical, administrative, and/or coordinator environment.
• Strong Verbal and Written Communication skills.
• Excellent interpersonal skills.
• Understanding of Good Documentation PracticesStrong organizational and prioritization skills.Ability to multi-task in a fast-paced environment
• Adept at attention to detail
• Strong understanding of Good Documentation Practices
• Familiarity with medical terminology.
• Work effectively and cooperatively with others; establish and maintain good working relationships.
• Computer literate-proficient in use of Microsoft Office. Must be able to understand and utilize complaint database software and reporting tools.
• Ability to multitask in a highly stressful environment