Supervisor, Quality Assurance

Employer
Bachem
Location
Vista, CA
Posted
Jul 14, 2021
Ref
693295801
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 Quality Assurance Supervisor fulfills a critical role for Quality Assurance. This individual will lead the QA team in supporting manufacturing activities. In addition, this individual is responsible for all quality assurance activities, including GMP documentation, batch record review, internal auditing. This individual must also provide GMP and related training to employees.

Your Tasks

  • GMP compliance improvements
  • Lead QA team in supporting manufacturing activities
  • Write performance reviews and manage a small team within the QA group
  • Oversee work of direct reports; distribute workload, and cross-train staff
  • Oversee deviations, CAPA and product complaints
  • Provide GMP and related training to company employees
  • Provide cGMP compliance guidance to other departments
  • Writing new and revising current standard operating procedures (SOPs), specifications, etc.
  • Conduct internal audits and write audit reports
  • Reviewing all GMP documentation, including BPRs and monitoring data
  • Reviewing trending data
  • Provide support to customer and regulatory audits
  • Recommends and implement new policies and procedures to improve existing processes and products
  • Writing and reviewing validation protocols, reports and master plans
  • Problem resolutions with GMP systems
  • Assist in the supervision of QA Specialists in supporting of manufacturing

Your Profile

  • Bachelor’s Degree in Chemistry or Biochemistry
  • Minimum of 5 years’ experience with GMP compliance
  • Experience in GMP manufacturing environment, Quality Assurance and Quality Control
  • Experience with GMP document control
  • Ability to lead QA team in supporting manufacturing activities.
  • Extensive experience in internal auditing as well as working with regulatory agencies
  • 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.