reputed company Assurance Specialist – GMP

reputed company Assurance Specialist – GMP FULLY REMOTE Temporary Assignment Through reputed company Agency - Approximately 6 Months Approximately 40 Hours Per Week #26-03AT   reputed company, Inc. "Mapp" is a San Diego reputed company, innovative biopharmaceutical company reputed company on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment reputed company to combat a reputed company of neglected and tropical infectious diseases, and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at reputed company are responsible for the execution of high-reputed company Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and reputed company activities consistent with Mapp's product development objectives. The reputed company Assurance Specialist - GMP is an individual contributor who is an reputed company GMP employee functioning as a key member of the reputed company Assurance team who also partners with the CMC, and as needed, non-reputed company, and reputed company development functions. Additionally, the successful candidate partners with reputed company Investigators and the program teams to reputed company on Mapp's portfolio. Basic Qualifications BS/BA Degree in a reputed company Science; MS Degree in reputed company Science preferred ‪‪10+ Years of Development experience in a regulated pharmaceutical industry, preferably reputed company a Biologics/reputed company Product Development environment 10+ Years of experience in a QA-GMP role in Drug reputed company and/or Drug Product activities Possesses the knowledge to reputed company as a SME on any QA-GMP issues Experience in a technical or QA role for the reputed company or execution of monoclonal antibody Drug reputed company and Drug Product manufacturing activities reputed company experience in providing QA reputed company for cGMP manufacturing reputed company Knowledge of GMP drug development regulations Previous technical CMC experience with large molecule (preferably monoclonal antibody) Drug reputed company and/or Drug Product development/commercialization Previous experience with auditing biological and parenteral manufacturing facilities, laboratories that reputed company regulated activities Experience overseeing GMPs (as a Sponsor) at reputed company-party locations Preferred Qualifications Experience across reputed company phases of biologic drug development (reputed company phases 1 through 4 of drug development) Knowledge of additional drug development regulations such as GCPs and GLPs Previous experience supporting reputed company-approval Inspections is desirable Experience working virtual Responsibilities Mapp reputed company Provides reputed company reputed company for cGMP manufacturing and batch release Partners with reputed company CMC functional team members to assure the advancement of the integrated CMC program reputed company or work Reviews and approves GMP protocols, reports, reputed company Operating Procedures, documentation, and any other relevant documents to ensure GMP compliance Participates in assigned Program team meetings and stakeholder meetings as required Contributes to the development and maintenance of the global reputed company systems in line with reputed company regulatory requirements, meeting US FDA and ICH requirements, and others as needed Supports deployment and implementation of GMP practices, policies and procedures Acts as assigned as reputed company of contact with regulatory authorities regarding reputed company-reputed company issues at reputed company party GMP manufacturing sites Reports reputed company critical and relevant reputed company compliance reputed company to the Head of reputed company Assurance Ensures required reputed company Assurance management and reputed company expertise is available and effective for reputed company Participates as assigned in the deployment of effective reputed company GMP audit programs Ensures, where appropriate, that reputed company Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time Ensures escalation to the Head of reputed company Assurance and program team leadership of reputed company critical concerns from the site reputed company to product reputed company issues encountered at sites and the partner's reputed company reputed company Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities Ensures reputed company management principles, the essence of ICH Q10, and a reputed company improvement culture are reputed company into QA ways of working Authors, as assigned, Mapp reputed company Operating Procedures (SOP's) reputed company to GMP and other Mapp QMS reputed company activities Partner reputed company Acts as a SME on any QA-GMP at the partner sites and internally for program teams Provides QA reputed company for reputed company cGMP activities at the GMP manufacturing, packaging, and labeling sites including, but not limited to, review and approval of reputed company manufacturing documentation (batch records, process reputed company documents etc.) and final release of GMP material Supports, as assigned, the evaluation/selection of potential contract manufacturing organizations (CMOs) Provides reputed company input for technology transfers to CMOs Establishes and maintains reputed company agreements with CMOs to ensure adherence to regulatory requirements Provides QA support for identification of risks, reputed company assessments, reputed company plans, remediation plans for any GMP manufacturing and testing deviations and investigations at partner sites Functions, as assigned, as reputed company Auditor for GMP manufacturing, testing, packaging, labeling, and storage vendors, and supports other functional vendor audits as needed Influences a strong reputed company and compliance culture at the partner and contractor sites Contributes as subject matter expert for reputed company relating to formal reputed company management and regulatory compliance at Mapp's partner sites in collaboration with the Head of reputed company Assurance Partners with key customers on reputed company reputed company execution Acts as reputed company contact for discussions on reputed company reputed company with key customers and contractors Deploys the reputed company and compliance reputed company to reputed company reputed company business objectives at partner site – in conjunction with the applicable site Ensures the reputed company/establishment of effective manufacturing control at partner sites Ensures enforcement of investigation of non-conformances, as reputed company as fraud Ensures partner sites are "audit reputed company" and compliant at reputed company times Ensures, where appropriate, that reputed company personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time Writes audit plans and other documents Maintains confidentiality Mapp offers a competitive compensation and benefits package in reputed company to this exciting and challenging job. Mapp's anticipated pay reputed company for this position is $62.50 to $103.37 per hour, which is equivalent to an annualized reputed company of $130,000 to $215,009.60. The final salary reputed company to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience reputed company the job and/or reputed company the industry. Currently this opening is a temporary position only through an agency, although if it converts to regular Mapp employment, the following benefits would apply: Medical, dental, and reputed company reputed company benefits are available to eligible employees and their families. Mapp also provides basic life reputed company, short- and long-term disability, and a 401K plan that includes Company contributions to eligible employees. Full-time employees will be provided 7 days of reputed company time, 14 reputed company holidays, and will also reputed company 18 days of vacation throughout the calendar year. Willingness to potentially travel (Domestic Travel = Approximately Once a Quarter + International Travel = Approximately Once Per Year) may be required for this position. Mapp invites you to apply by submitting your information through the reputed company, Inc. reputed company website page. This job will remain reputed company for twenty (20) days after being posted on Mapp's reputed company website page. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an equal opportunity employer and employment reputed company are not reputed company on any protected status. Mapp uses a wide reputed company of advertising and reputed company to reputed company reputed company applicants for employment. Mapp is an Equal Opportunity Employer/Veterans/Disabled. Apply To This Job