GMP QC Specialist — Lab, Cleanroom & Data

Musculoskeletal Transplant Foundation; Edison (NJ); Presencial; USD 44.000 - 47.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

4 weeks PTO

Medical, Dental, Vision Insurance

401K with company match

Life & Disability Insurance

Tuition Reimbursement

Descripción de la vacante

Musculoskeletal Transplant Foundation is seeking a QC Specialist to support multiple QC functions, perform environmental sampling, titration testing, and inspect supplies. You will maintain accurate records in LIMS and logs, coordinating with internal and external labs while escalating discrepancies to management.

Shift: Mon-Fri 8AM-4PM. Pay Range: $32-$34/hr. This role emphasizes ISO-classified environment qualification and adherence to GMP/FDA requirements.

Formación

• Bachelor in Science or 3 years GMP/Regulated Industry related experience
• 2 years QA/QC experience in GMP or FDA regulated industry
• Maintain gowning/gloving qualification for ISO classified areas and demonstrate good laboratory practices
• Operate laboratory equipment and software systems; interpret data accurately

Responsabilidades

• Perform Quality Control tasks across clean rooms, laboratories, and calibration systems
• Analyze samples per OPs/WIs and ensure hold time requirements
• Coordinate sample submissions with internal and external laboratories; escalate discrepancies to management
• Review and document data; support investigations and corrective actions led by QC Management or QE
• Maintain accurate logs and correspondence to ensure data integrity and traceability

Conocimientos

GMP/regulatory experience

Data entry & record keeping

Communication skills

Laboratory software usage

Educación

Bachelors in Science

Herramientas

LIMS

Microsoft Excel

Microsoft Word

Microsoft Outlook

Descripción del empleo

Musculoskeletal Transplant Foundation is seeking a QC Specialist to support multiple QC functions, perform environmental sampling, titration testing, and inspect supplies. You will maintain accurate records in LIMS and logs, coordinating with internal and external labs while escalating discrepancies to management.

Shift: Mon-Fri 8AM-4PM. Pay Range: $32-$34/hr. This role emphasizes ISO-classified environment qualification and adherence to GMP/FDA requirements.