Document Control Specialist in Berkeley, CA at Apex Life Sciences

Date Posted: 9/15/2018

Job Snapshot

Job Description

The Document Control Specialist will manage the quality documentation system, change management, and Training program.  This is an exceptional opportunity to gain experience in a successful biotech company.

Responsibilities include, but are not limited to:

  • Maintain and organize files on a manual document control system, in electronic and hard copy
  • Manages the routing, review, distribution and archival of new and revised controlled documents (Internal and external).
  • Maintain and Track quality Metrics (such as deviations / non-conformances, Lot genealogy, stability program, retest / expiry of APIs, drug products and reference standards)
  • Generate and make effective master formulation records, master manufacturing batch records, specifications, CTM labels, and other quality related documentation
  • Create or manage revisions of Standard Operating Procedures (SOPs)
  • Manage training and Maintains training records for all personnel
  • Identify and review Quality issues, develop proposals and make informed decisions with input from QA management. Implement decisions and/or corrective actions, etc. concerning development products
  • Other duties as assigned

Position Requirements & Experience:

  • Bachelor’s degree in related field required (or relevant experience)
  • At least 3 years of experience in a cGMP QA and/or pharmaceutical laboratory environment – preferred
  • The ideal candidate should be capable of independent decision making with a high degree of initiative
  • Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
  • Detail and team oriented.
  • Desire to learn and tackle new challenges is imperative
  • Comfortable in a fast-paced small company environment with minimal direction and to adjust workloads based upon changing priorities
  • Advanced Skills with Microsoft Office Suite (Word, Excel, and PowerPoint)
  • Audit experience a plus
  • Knowledge of FDA regulatory requirements for small molecules a plus

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.