Complaints Specialist, Quality

Scorpion Therapeutics; Pennsylvania; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical/dental/vision

401k retirement plan

Paid holidays/vacation

Sick/compassionate days

Job summary

Scorpion Therapeutics is seeking a Quality/Compliance professional to lead customer complaint investigations and CAPA processes in a GMP manufacturing environment.

You will partner with cross-functional teams, draft regulatory notifications, and support quarterly governance meetings to drive continuous improvement and ensure product quality and regulatory readiness.

Qualifications

• Bachelor's degree or equivalent GMP/regulatory experience is required.
• 1+ year post-degree experience in GMP manufacturing/lab or pharmaceutical/biological quality or regulatory support required.
• Preferred: experience as a customer complaint investigator or deviation investigator in biologics/vaccine facilities.

Responsibilities

• Lead customer complaint investigations including root-cause, scope, and CAPA identification.
• Complete investigational test protocols to determine root cause and impact where applicable.
• Author notifications to Health Authorities in response to complaints as required.
• Support complaint work-in-progress in tier meetings and manage complaint trackers.
• Facilitate Complaints Governance, COP, and Health Authority Assessment meetings.
• Collaborate across IPT areas to drive robust processing and continuous improvement.
• Perform retention sample and batch record evaluations as applicable.
• Draft/review BPDR and AEQIRs as needed.
• Support team/site safety, environmental and compliance objectives.
• Use Production System tools in problem-solving and daily complaint activities.

Skills

cGMP compliance

CAPA management

customer complaint management

data analysis

documentation/records review

FDA regulations

quality inspections/operations

process improvements

Education

Bachelor's degree in Life Sciences/Science/Engineering

4+ years direct GMP manufacturing/lab or regulatory experience in lieu of degree

Job description

Responsibilities

• Lead customer complaint investigations, including second-person review, root-cause determination, event scope, product impact assessment, and CAPA identification.
• Where applicable, complete investigational test protocols to determine root cause and impact.
• Author notifications to applicable Health Authorities in response to complaints (as required).
• Support complaint work-in-progress in tier meetings/huddles; assign workload and manage complaint trackers.
• Facilitate Complaints Governance, Complaints Community of Practice (COP), and Health Authority Assessment meetings.
• Collaborate across IPT functional areas to drive robust processing and continuous improvement (including proactive process improvements and investigation CAPAs).
• Perform retention sample and batch record evaluations (as applicable).
• Draft/review/support Biological Product Deviation Reports (BPDR) and Adverse Event Quality Inspection Reports (AEQIRs).
• Support team/site safety, environmental, and compliance objectives.
• Use and champion Production System tools in problem-solving and daily complaint activities.

Qualifications

• Required Education: Bachelor’s degree in Life Sciences/Science/Engineering (preferred); or 4+ years direct GMP manufacturing/lab or regulatory experience in lieu of degree.
• Required Experience: 1+ year post‑degree experience in GMP manufacturing/lab or pharmaceutical/biological quality, operations, technical, or regulatory support.
• Preferred: Customer complaint investigator/complaints support; deviation management investigator; biologics/vaccine/bulk sterile facility experience.

Required Skills (examples)

cGMP compliance, CAPA management, customer complaint management/resolution, data analysis, documentation/records review, FDA regulations, quality inspections/operations, process improvements.

Benefits (if applicable)

• medical/dental/vision
• retirement (401k)
• paid holidays/vacation
• sick/compassionate days