Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

QA Compliance Specialist I

Expired Job

NJ Employer East Hanover , NJ 07936

Posted 4 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.

upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
QA Documentation Specialist

Novartis Pharmaceuticals

Posted 3 weeks ago

VIEW JOBS 12/22/2018 12:00:00 AM 2019-03-22T00:00 Job Description Maintenance of the Master Batch Record (MBR) life cycle management in a compliant and secure manner per cGMP regulatory requirements and in accordance with the NVS Quality Manual. • Maintain and follow CGTDM procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving. • Print and issue batch records, in-process labels, and final product labels to support operations. • Issue labeling/tags for Apheresis through packaging of final product labelling to QA/Operations. • Maintain the executed Batch Records until final archiving and in accordance with CGTDM retention schedules. • Enter/maintain information accurately following GDocP to support operations and overall life cycle of documents and records. • Manage document control room and GxP document lifecycle management activities such as filing, archiving, providing execution copies, etc. • Assist with batch record disposition of development/clinical phase product, raw materials and media. • Assist with reviewing and approving manufacturing and QC related documents for batch record disposition. • Assist with reviewing and approving QC/ Micro and BioAnalytics data in support of testing performed for batch record disposition. • Initiates, Reviews and approves deviations, CAPAs, change controls, facility Work Orders, and any other site/product related documents ensuring adequate levels of documentation are adequate and compliant to existing procedures. • Ensure the Disposition process meets industry and Novartis expectations and requirements. Drive continuous improvement and enhancement efforts to the Disposition process to ensure an efficient yet Compliant process is maintained Employment Type Regular Novartis Pharmaceuticals East Hanover NJ

QA Compliance Specialist I

Expired Job

NJ Employer