Manager, Quality Assurance

Employer
Bachem
Location
Vista, CA
Posted
Jul 16, 2021
Ref
684755301
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 Manager is responsible for operations related Quality Assurance activities including; the manufacturing floor quality oversight, GMP documentation, batch record review and batch release.

Your Tasks

  • Oversee and support implementation of electronic document control modules (Master Control) and ERP system (SAP)
  • GMP compliance improvements
  • Writing new and revising current standard operating procedures (SOPs), specifications, etc.
  • Auditing Production, Materials Management, and Quality Control functions
  • Writing internal audit reports
  • Support customer & regulatory audits. Responding to audit observations
  • Reviewing all GMP documentation, including BPRs, SOPs, Specifications, Protocol, and Reports
  • Reviewing trending data, Change Controls, Deviations, and CAPA’s
  • Problem resolutions with GMP systems

Your Profile

  • Bachelor’s Degree in Science related field, Chemistry, Biochemistry, Biology etc.
  • Minimum of 5 years’ experience in a GMP/regulated industry
  • Minimum of 3 years in QA management position
  • Experience in GMP manufacturing environment, Quality Assurance, Quality Control
  • Experience with 21 CFR Parts 110, 111, 210, 211, ICH Q7
  • Experience with GMP document control
  • Experience in both internal and external auditing
  • Ability to work with regulatory agencies
  • Strong supervisory skills and technical writing skills
  • 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.