Job description

Job Title: PQC Associate/Analyst (Onsite from Day1)
Location: Bridgewater, NJ - 08807 and the role is onsite - Vaccination is mandatory

12+Months Contract

Job Description:

• Interacts with complainants and obtains essential information required to document technical complaints
• Provides customer service and support to meet the needs of the complainants
• Identifies and confirms inquiries as product technical complaints.
• Evaluates complaints for severity and risk to public safety.
• Notifies interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints.
• Monitors and tracks sample receipt from critical complaints.
• Ensures complaints are reviewed and processed within a timely fashion.
• Prioritizes complaints for data entry and processing into the department PTC database.
• Utilizes the customer service database to oversee complaint identification and processing.
• Monitors complaint activity for assigned manufacturing sites.
• Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations.
• Identifies complaints for field alert reporting
• Performs QC Checks
• Understands FDA complaint regulations for drug products and medical devices.
• Performs file review and administrative closure for individual complaints.
• Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity.
• Monitors open complaint activity for each manufacturing site.
• Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints.
• Identifies and reports adverse events within one business day to Pharmacovigilance.
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.
• Participates on ad-hoc teams regarding product-specific complaint issues.
• Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
• Understands product specific information regarding common product complaints.
• Understands department process flows and complaint databases.
• Provides feedback to customers regarding complaint investigations.
• Performs other duties as assigned.

KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE

• Minimum of 3 to 5 years of related experience within the pharmaceutical industry.
• Strong Verbal and Written Communication Skills
• Problem Solving Skills
• Adept at Attention to Detail
• Strong understanding of Good Documentation Practices
• Good organizational skills
• Analytical skills
• Self-motivated/directed
• Computer literate—proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools.
• Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics
• Project and Time Management Skills
• Interpersonal skills-must be proactive, personable, flexible, team-oriented
• Customer Service Skills
• Ability to multitask in a highly stressful environment
• Ability to operate in a constantly changing environment

Educational Background
Bachelor’s degree in a science discipline preferred.
High-school level command of spelling, grammar, and math, and/or basic vocational skills training (e.g., high school diploma, general education degree)
Up to two years of formal post-high school specialized trade school, technical school, or college
Area of specialization:
Associate’s degree from an accredited two-year college or technical school
Area of specialization: Health or Life Sciences preferred

Vaccination is mandatory

Job Type: Contract

Pay: $20.00 - $25.00 per hour

Benefits:

• 401(k)
• Health insurance

Schedule:

• Day shift

Work Location: In person

Speak with the employer
+91 847-474-3706

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