Quality Systems Document Control Specialist in El Segundo, CA at Apex Life Sciences

Date Posted: 7/30/2018

Job Snapshot

Job Description


A well-regarded company focusing on patient therapies is seeking a Quality Systems Document Control Specialist to join their team. This is a great opportunity to work for an industry leader!

DUTIES AND RESPONSIBILITIES:

  • Maintain a document management system compliant with regulatory, quality, and company requirements
  • Responsible for the management of all lot documentation and records issuance processes to support clinical and commercial manufacturing
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the lot document management system.
  • Responsible for enhancing and maintaining the document change control system for batch record issuance and label issuance.
  • Executes strategic initiatives to improve the document management system associated with batch record issuance and label issuance.
  • Executes improvement projects to enable process efficiencies in the batch record issuance and label issue team.
  • Collaborates with cross-functional departments to ensure timely implementation of changes to the batch record and label issuance system.
  • Prints, compiles and issues all lot related documentation (batch records, labels, sample plans, specifications etc)
  • Investigates deviations against the lot documentation and records issuance system and develops effective corrective action plans
  • Develops or enhances training content for batch record and label issuance processes and procedures
  • Provides training to new staff on batch record and label issuance processes and procedures.
  • Quality record owner (deviations, CAPA, CC) associated with batch record and label issuance processes and procedures.
  • Perform other duties as required.

REQUIREMENTS:

  • Bachelor’s Degree and a minimum of 2 years of experience OR Master’s Degree and a minimum of 1 year of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
  • Strong knowledge of GMP, SOPs and quality system processes.  
  • Excellent organizational skills and ability to review processes or procedures.
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent).
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Experience in pharmaceutical or bio-pharmaceutical field.
  • Education or training in cell culture and gene therapy manufacturing environment a plus.
  • Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). 

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 employeeservices@apexsystemsinc.com or 844-463-6178.

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 employeeservices@apexsystemsinc.com or 844-463-6178.