Focus on the review and approval of technical documents pertaining to GMP analytical methods for biologics drug substances and drug products.
Specific technical document types include analytical methods, method protocols and reports, reference standard and critical reagent protocols and reports and COAs, certificates of analysis, analytical change controls and general procedural documents.
Partner with analytical functional areas to resolve associated protocol deviations and other exceptional conditions
Assist with CAPA identification and resolution.
Review and approve analytical method protocol and reports.
Review and approve qualification and assessment protocol and reports.
Review and approve GMP procedures.
Review and approve change controls, CAPAs and Effectiveness Checks.
Review and approve protocol exceptions/deviation.
6+ years of experience in an FDA regulated biotechnology or pharmaceutical industry.
4+ years of experience in QA/QC in GMP or GDP environment.
Working knowledge of QC and analytical test methods for biologics/pharma products.
Previous experience in QC laboratory executing analytical methods.
Experience with reviewing deviations/non conformance/or protocol exceptions is desirable.
Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity).
Ability to manage multiple priorities with aggressive timelines
Excellent written, verbal communication and technical writing skills.
Strong interpersonal skills and ability to work in a matrix team environment.
Knowledge of FDA and cGMP regulations and documentation practices.
Strong problem solving, conflict resolution, negotiation and independent quality decision making skills.
Strong ability to coach/mentor and is self directed.