Quality and Compliance Specialist

Piramal Pharma Solutions; Riverview (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan seeks a qualified Quality and Compliance Specialist to join our Quality Control team. The role reviews laboratory data and reports to ensure accuracy, integrity and GMP compliance, with responsibility for release of certain GMP materials.

Key tasks include data review of HPLC, GC, KF and other tests, deviation investigations, and alignment with QA and engineering on continuous improvement of data systems

Qualifications

• Bachelor's degree in Chemistry, Biochemistry or related field.
• 2–5 years of GMP laboratory data review experience.
• Experience with HPLC, GC or related analytical techniques is a plus.
• Technical writing experience.

Responsibilities

• Review analytical data, raw materials, intermediates and finished products per cGMP standards.
• Release of starting materials and cleaning validations/verifications for GMP manufacturing.
• Interface with supervisor, analytical groups and QA daily.
• Review deviations for accuracy and data integrity, procedures, and cGMP compliance.
• Review reports for accuracy and completeness (method validation, stability, calibration).
• Support investigations (OOS, deviations, CAPAs) when needed.
• Assist in preparing updated or new documentation as required.
• Participate in continuous improvement initiatives related to data acquisition and electronic review.

Skills

GMP compliance

Data integrity

Quality control

Documentation

Education

Bachelor's degree in Chemistry or Biochemistry

Tools

ECM OpenLab

SAP

TrackWise

LIMS

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, 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 the review of the laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP and data integrity standards. They are responsible for the release of some GMP materials.

Key Responsibilities.

• Review IPC, raw materials, intermediates, and finished products analytical data, as well as cleaning validation/verification data according to cGMP, GDP, in a timely manner.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing
• Interface with their supervisor, the analytical group(s) and QA on a daily basis.
• Review of deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations
• Document review includes review of sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms, and electronic data and audit trails
• Review of a variety of data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing
• Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.
• Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
• Assist in the preparation of new or revised documentation as required.
• Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
• Revise via change control documentation as required
• Perform other related assignments and projects as required

Experience/Education.

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• Minimum two (2) to five (5) years of experience in using 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
• Minimum two (2) years of GMP laboratory experience.
• Ability to monitor, coordinate and prioritize work in an effective and efficient manner.
• Must be a self-motivated, proactive team member to manage work within quality projects and timelines.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.