• Job Type:Contract

Posted 4 days ago

Job Description:

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 company, with focus on the global PQC process.

Roles and Responsibilities:

• Provide ongoing management for PQCs ensuring compliance to global framework of GMP policies and company

• 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 company 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.

• Must have strong analytical, interpersonal, communication, organization, and project management skills and passion to learn and grow within the biopharmaceutical industry.

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

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.