Quality Assurance Data Reviewer

Job Overview

CMIC CMO USA

is seeking a detail-oriented Quality Assurance Data Reviewer to support Quality Assurance and Quality Systems activities within a cGMP pharmaceutical manufacturing environment. This role is responsible for reviewing analytical and quality documentation, conducting audit trail reviews, evaluating investigations and change controls, supporting audits and inspections, and ensuring compliance with FDA regulations, ICH guidelines, and internal quality standards. The ideal candidate will possess prior Quality Control laboratory experience, a strong understanding of QC procedures, documentation, and analytical testing processes, as well as working knowledge of pharmaceutical quality systems, data integrity requirements, and cGMP regulations. This individual must be able to collaborate effectively across departments to maintain the highest standards of quality and compliance. Responsibilities Support the Quality Management System for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/ICH guidelines. Review and approve laboratory instrument qualification, calibration, and analytical method validation protocols and reports. Evaluate Change Controls, Deviations, Laboratory Investigation Reports (LIRs), OOS, OOT, and COT events to ensure appropriate root cause determination and quality impact assessments. Review and assess change controls and associated risk assessments. Conduct periodic Audit Trail Reviews to ensure compliance with data integrity requirements. Participate in customer audits, regulatory inspections, and internal audit activities. Perform audits of contractor facilities, laboratories, warehouse operations, engineering, validation, IT systems, and manufacturing operations. Assist in the development, review, and approval of specifications for raw materials, packaging components, APIs, in-process materials, and finished products. Participate in SOP development, revisions, implementation, and training activities. Collaborate cross-functionally with Quality Control, Manufacturing, Validation, Engineering, Supply Chain, and other departments on quality-related activities. Maintain compliance with company procedures, cGMP requirements, and applicable regulatory standards. Experience 3-5 years of Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review experience within a pharmaceutical, biotechnology, or other regulated life sciences environment. Experience reviewing quality documentation, investigations, deviations, change controls, and CAPA activities. Experience supporting regulatory inspections and/or customer audits preferred. Experience performing audit trail reviews and working with data integrity requirements preferred. Prior experience working in or directly supporting a pharmaceutical Quality Control laboratory is required. Demonstrated knowledge of Quality Control laboratory procedures, documentation practices, and cGMP requirements. Experience reviewing QC documentation, including analytical test records, laboratory investigations, specifications, method validation reports, instrument qualification documentation, and laboratory logbooks. Familiarity with analytical instrumentation and laboratory data generated from systems such as HPLC, GC, Dissolution, UV, FTIR, TOC, Karl Fischer, and related laboratory equipment. Experience reviewing OOS, OOT, deviations, change controls, CAPAs, and laboratory investigations is strongly preferred. Education Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Quality Assurance, Regulatory Affairs, or a related scientific discipline. Actual compensation will be based on qualifications, experience, skills, and business needs.

Pay:

$31.00 - $35.00 per hour

Benefits:

401(k) Dental insurance Disability insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance

Work Location:

In person