Job description

Job Title: PQC Analyst

Location: New Jersey

Duration: 11 Months

Job Description:

This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance, and complaint handling is required. Maintains onsite sample room and mailroom as per departmental SOP.

Responsibilities
Prioritizes complaints about 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 the use of all databases within the department (i.e.. 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 about 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 needed
Provide 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
Associate degree with experience in a pharmaceutical, administrative, and/or coordinator environment or bachelor’s degree (science discipline preferred) + years of experience in a pharmaceutical, administrative, and/or coordinator environment.
Area of specialization: Health or Life Sciences preferred

Preferred Qualifications/Skills
Excellent Verbal and Written Communication skills.
Excellent interpersonal skills.
Understanding of Good Documentation Practices
Good 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

Job Type: Contract

Salary: $30.00 - $35.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Jersey City, NJ 07302: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Product Technical Complaints: 4 years (Preferred)
• Field Alerts: 3 years (Preferred)
• Medical devices: 3 years (Preferred)
• pharmaceutical products: 3 years (Preferred)
• Biologics: 3 years (Preferred)
• GMP, GDP, quality & compliance, and complaint handling: 3 years (Preferred)

Work Location: One location

Speak with the employer
+91 9030449922

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