- Expiry Date: 06 June 2022
- Referral: email@example.com
The AQ&C Specialist will focus on Quality Assurance (QA) review and approval of technical documents pertaining GMP analytical methods for biologics (large molecules) drug substances and drug products.
The scope of documents will range from early clinical development through registration and commercial lifecycle of methods.
Specific technical document types include analytical method procedures, method validation protocols and reports, method transfer protocols and reports, reference standard and critical reagent qualification protocols and reports, certificates of analysis, analytical change controls and general procedural documents.
This QA role will alspartner with analytical functional areas resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.
Performs the QA review/approval of technical documentation, including but not limited to
Analytical method validation protocols and reports for in process, release, and stability testing.
Analytical method procedures and associated change controls.
Method technical transfer protocols and reports.
Reference material and critical reagents qualification protocols and reports.
Standard Operation Procedures and other controlled documents.
Collaborate with clinical or commercial analytical functions determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related validation or technical transfer of analytical methods or qualification of reference material and critical reagents.
Communicate, share and escalate issues within team for consensus resolution.
Assist in the development of procedural and other guidance documents for Quality and QC functions.
Chemistry or biology degree highly desirable.
QA for QC lab highly desirable (very important someone whhas worked directly with QC lab as document reviewers for method validation, tech transfer validation, and laboratory investigations Skills.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.