This site uses cookies. To find out more, see our Cookies Policy

Batch Record Review Specialist in Allentown, PA at Apex Life Sciences

Date Posted: 12/3/2018

Job Snapshot

Job Description


Batch Record Review Specialist

Summary 
Responsibilities include review of line documentation related to contract packaging. Will follow-up on customer inquiries as they relate to documentation and compliance issues. Position is final review and ultimate release for product distribution. 

Responsibilities

  • Responsible for review of documentation related to primary and secondary packaging after completion of reconciliation. 
     
  • Responsible for critical review of all above documentation for errors, omissions, over-writes and compliance to cGMPs. 
     
  • Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product. 
     
  • Responsible for final release of work in-process or finished product. 
     
  • Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management. 
     
  • Responsible for training of designated peers as a replacement. This is completed at management’s request. 
     
  • Responsible for maintaining status spreadsheets 

Qualifications

  • AS or BS with 1-3 years of experience
  • High school diploma with 4 or more years of experience
  • Candidates that do not have prior experience with documentation in an FDA regulated environment will not be considered

For consideration, please send all resumes to Jillian Petillo at jpetillo@apexlifesciences.com

EEO Employer

Apex 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 844-463-6178.




918900