Product Complaint Specialist
Company: Alpha Consulting
Location: New Brunswick
Posted on: May 24, 2023
PRODUCT COMPLAINT SPECIALIST NEW BRUNSWICK, NJHybrid Role. Must
be an enrolled student.Required Skills:
- BS/BA in Sciences (i.e. Chemistry, Biology, Biochemistry,
Microbiology, Pharmacy), engineering, business.
- Enrolled in Bachelor's, master's, or MBA degree program.
- Preferred Completion of bachelor's and enrolled in graduate
- Microsoft Office (Power point, Excel, Word, Outlook).
- Project Management expertise with advanced PowerPoint
- 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. Project
- 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
- 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 BMS, with focus on the global PQC process.
- Provide ongoing management for PQCs ensuring compliance to
global framework of GMP policies and BMS 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 BMS 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
- 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. This 6+ month position starts ASAP.Please E-MAIL
your resume (attachment to email) with rate and availability to
Jacqueline: ALPHA'S REQUIREMENT #23-00811MUST BE ELIGIBLE TO WORK
IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting, New Brunswick , Product Complaint Specialist, Other , New Brunswick, New Jersey
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