Quality Assurance Manager, Document Control

Employer
Bachem
Location
Vista, CA
Posted
Jul 16, 2021
Ref
684759601
Hotbed
Biotech Beach
Required Education
Bachelors 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 Manager of Document Control, Labeling/Packaging and Training plays an essential leadership

role in the effective application of the Training, Labeling, and Documentation systems. This position

will also ensure compliance to quality objectives, business demands, and necessary harmonization

effort to improve process efficiency.

Your Tasks

  • Leadership and development of a team consisting of QA coordinators and assistants.
  • Establishes and maintains procedural framework for identifying, collecting, distributing and filing the controlled documents for the company. This involves writing and maintaining document control procedures and participating in the development and rollout of document control tools, such as scanning hardware, computer software.
  • Responsible for improving and ensuring compliance associated with filing, tracking and archival of documentation.
  • Responsible for evaluating shipment dataloggers using Libero Manager software
  • Maintains databases used for tracking various GMP documentation
  • Manages electronic document and training modules of MasterControl
  • Works directly with all levels and departments, including Central Function QA to establish accurate training curriculums and assignments based on assigned functions.
  • Ensures timely and accurate retrieval of product release data packages, batch production records, personnel training records, and necessary controlled document to support internal/external audits and regulatory inspections.
  • Liaises with functional departments to coordinate training on new or revised procedures.
  • Manages generation and/or revision of GMP documentation such as standard operating procedures, logbooks, and labels.
  • Tracks, trends and monitors training compliance; prepares routine progress reports on job specific training programs for management.
  • Uses data driven methods to identify areas for continuous improvement of training materials, document control system, and labeling process.
  • Other tasks as assigned

Your Profile

  • Bachelor’s Degree in Chemistry, Biochemistry, Biology or related field
  • Proficient with Microsoft Office Suite of software, Adobe Acrobat, Document Control Software, and Labeling software
  • Demonstrated experience with routine Document Control hardware and software, such as scanners and binders
  • Proficiency in training systems within the cGMP environment, including working with facility training program
  • Familiarity with current Good Manufacturing Practices (cGMP), 21 CFR 210, 21 CFR 211, and ICH Q7
  • Strong 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
  • Communicate effectively and ability to function well in a team environment
  • Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment
  • Working Experience in a cGMP regulated environment is required, 5 years minimum
  • 2+ years of experience in a management role, and experience in advising and influencing internal stakeholders
  • Strong ability to work independently, manage one’s time, and ensuring team members meeting relevant department goals
  • Proven accuracy, reliability and completeness in job accomplishment
  • Excellent attention to detail

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.