QA Compliance Specialist I
East Hanover , NJ 07936
Posted 2 months ago
DescriptionDuties:Coordinate and support the audit function for vendors, suppliers, service providers and contracts.Coordinate and support the communication of the audit schedule and executing to plan as required by local procedures and regulatory requirements.Support in external audits; provide written reports and observations in a timely manner and assure correctives are adequate and timely. Support the AQWA FURP and QARP Coordination for the facility as needed with external audits.Manage and support the vendor change notification/implementation program.Support local Principle Investigator (PI) certification
Support on quality manual implementation teams in area of technical expertise as required.Participate and coordinate in the client's internal audits.Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments.Assist and participate in regulatory inspection activities as required.Work with site personnel to ensure completion of all regulatory commitments.Support maintenance of central file for correctives and inspection history.Coordinate and participate in the training of personnel on local auditing practices and any corporate policy / standards as required.Coordinate and support the approval process for new vendors / materials.Coordinate and support the Raw Material Review Board and Raw Materials Vendor Changes meeting.Skills:
Bachelors or higher in Chemistry, Pharmacy, Microbiology or other related science or work experience.5+ years of related pharmaceutical experience to include cell gene therapy preferred.Quality Assurance, packaging, manufacturing, auditing and / or technical report writing experience also preferred.EEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.