Complaints Specialist, Quality

Merck • Upper Gwynedd Township, PA

4d • $87,300 - $137,400 • Onsite

About The Position

West Point Quality Operations is seeking a highly motivated individual to provide complaint investigation support for vaccine manufacturing. The primary focus of the role is customer complaint investigation. The role may also include process improvements, batch data analysis, and support for regulatory inspections. Specific assignments may be focused in one operational area or span multiple areas.

Requirements

• Bachelor’s degree. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
• In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.
• Minimum 1 year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or Laboratory Operations, or related industry experience.
• Adaptability
• Aseptic Manufacturing
• CAPA Management
• cGMP Compliance
• Competency Management
• Customer Complaint Management
• Customer Complaint Resolution
• Data Analysis
• Decision Making
• Documentation Review
• Environmental Stewardship
• Equipment Troubleshooting
• FDA Regulations
• Interpersonal Relationships
• Laboratory Operations
• Laboratory Quality Control
• Operational Quality
• Process Improvements
• Progress Monitoring
• Project Management
• Quality Inspections
• Quality Operations
• Quality Reporting
• Records Review

Nice To Haves

• Customer Complaint investigator or previous complaints support
• Prior Deviation Management investigator
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

Responsibilities

• Performing investigations and second person review for customer complaints aimed to prevent recurrence, including determining the root cause, identifying Corrective/Preventative actions (CAPAs), identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• Authoring notifications to applicable Health Authorities, in response to complaints, as required.
• Supporting the customer complaint work-in-progress at tier meetings/huddle, including assigning of workload and managing all relevant complaints trackers
• Complaints Governance meeting, Complaints Community of Practice (COP), and Health Authority Assessment meeting to evaluate complaints, facilitate the discussions to align with Technology and Quality approvers / representatives and site leadership.
• Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements and investigation CAPAs.
• Retention sample and batch record evaluation as applicable.
• Drafting/review/support of Biological Product Deviation Reports (BPDR) and Adverse Event Quality Inspection Reports (AEQIRs).
• Supporting team and site safety, environmental, and compliance objectives.
• Actively using and championing the use of our Company Production System tools, both in problem solving and day-to-day complaint activities

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level