GMP Quality & Compliance Specialist – QC Data Review

Piramal Pharma Ltd; Riverview (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality and Compliance Specialist to join our Quality Control team. The Quality and Compliance Specialist is responsible for reviewing laboratory data, ensuring methods and procedures are followed, and that all documentation meets GMP and data integrity standards.

They are responsible for the release of some GMP materials and will interface with

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• 2–5 years of experience with HPLC, GC, and/or related analytical techniques. QC data review experience a plus.
• Knowledge of ECM OpenLab, SAP, TrackWise, LIMS a plus.
• Technical Writing Experience and GMP laboratory experience.

Responsibilities

• Review IPC, raw materials, intermediates, and finished products analytical data according to cGMP, GDP.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing.
• Interface with supervisor, analytical groups, and QA daily.
• Review deviations for accuracy, completeness and data integrity; verify procedures.

Skills

Attention to detail

Communication skills

Organizational skills

Self-motivated

Time management

Education

Bachelor’s degree in Chemistry/Biochemistry or related field

Tools

ECM OpenLab

SAP

TrackWise

LIMS

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality and Compliance Specialist to join our Quality Control team. The Quality and Compliance Specialist is responsible for reviewing laboratory data, ensuring methods and procedures are followed, and that all documentation meets GMP and data integrity standards.

They are responsible for the release of some GMP materials and will interface with