Job description

This is a Hybrid Role

Position Summary

• Support the Global Product Quality Complaint (PQC) process for the biosterile, pharmaceuticals and combination drug/device products with respect to product quality complaints.
• Analyze, identify and execute continuous improvement initiatives within the process while collaborating within the PQC headquarters team as well as with key stakeholders, including internal and external sites and in-market supply chain quality.
• This individual will be a valued team member of one of several cross-functional, multi-divisional teams which are responsible for developing and executing Global Quality Systems (GQS) initiatives and strategies for Client, with focus on the global PQC process.

Roles and Responsibilities:

• Provide ongoing management for PQCs ensuring compliance to global framework of GMP policies and Client procedures
• Support the Global Product Quality Complaint (PQC) processing activities at PQC Headquarters.
• Participate in PQC HQ team meetings for the processing of, and improvements to, global Client PQC processes, including but not limited to: PQC case intake, triage, due diligence activities, product replacements and patient reimbursements/refunds; metrics generation and slide presentation; PQC training delivery and management; new product launches; PQC related Quality Management System (QMS)
• Support tracking, trending and other ancillary activities for controlled documents (SOPs/Job Aids/Templates); record archivals; quality deviations and CAPA involving PQC HQ and provide quality and compliance support for these processes.
• Assist in implementation of Quality Risk Management principles in evaluation and investigation of PQCs.
• Support PQC related audits and inspections as necessary. Participate in QMS business process requirements development and validation activities as necessary.
• This opportunity is cross functional and will involve the management of mid-size projects between PQC HQ and other areas of the organization.

Qualification Requirements

Education:

• BS/BA in Sciences (i.e Chemistry, Biology, Biochemistry, Microbiology, Pharmacy), engineering, business.
• Enrolled in Bachelor’s, Masters or MBA degree program. Preferred Completion of Bachelors and enrolled in graduate studies.

Experience/Knowledge

Skills/Competencies:

• Microsoft Office (Power point, Excel, Word, Outlook)
• Project Management expertise with advanced PowerPoint preferred
• Basic statistics/analytics; clear communications
• Ability to manage deliverables within target timelines
• Must have strong analytical, interpersonal, communication, organization, and project management skills and passion to learn and grow within the biopharmaceutical industry

Job Type: Contract

Salary: $20.00 - $25.00 per hour

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Ability to commute/relocate:

• New Brunswick, NJ 08901: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• complaints: 1 year (Preferred)
• quality assurance: 1 year (Preferred)
• pharma or medical device industry: 1 year (Preferred)

Work Location: One location

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