QA Specialist I (Document Control)

Employer
Bachem
Location
Torrance, CA
Posted
Jul 23, 2021
Ref
592604701
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Quality Assurance Specialist I (Document Control) fulfills a critical role for Quality Assurance. The primary function of this individual will support all activities related to the Document Control function, including the review and release of SOPs, Forms, Specifications, Batch Records, Plans, Protocols, Reports, etc. through Master Control. This individual will support record management ensuring that the site stays in compliance with FDA and international regulatory requirements.

Your Tasks

  • Review and process all submitted documents through Master Control System in a timely manner, meeting monthly, quarterly and annually department goals
  • Issue logbooks, active and retired documents as required to meet department goals
  • As necessary, perform scanning of completed GMP documentation (Batch Records, QC Data compile TSE certificates for creation of RMSS certification)
  • As necessary, upload CofA and Retest certificates into Master Control
  • Perform Doc Control function in Master Control to support organizational needs
  • As required by the department, responsible for records management procedures and processes including documentation, record retention, archival and retrieval Including organization and update of the document room file as required
  • Create and revise product Master Labels in conjunction with corresponding specification creation/revision
  • Provide support for customer and regulatory audits; participate in responses to QA related observations
  • Implement improvements in quality systems and SOPs and QA owned documents
  • Represent QA in process improvement project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes)

Your Profile

  • A Bachelor’s Degree in Science or related field and a minimum of 1 years’ experience in a GMP setting or
  • Associates Degree in Science or related field and a minimum of 3 years’ experience in a GMP setting or equivalent experience
  • Minimum of 1 years’ work experience in a Document Control function
  • Ability to collaborate cross-functionally between departments to provide effective support and ensure timely execution of associated tasks
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.