QC Manager RM BSD

Employer
Bachem
Location
Vista, CA, US
Posted
Nov 10, 2020
Ref
631544201
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Your Responsibilities

The Manager of Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations within the Quality Control (QC) department. This individual manages all raw material qualification, water system testing, environmental monitoring and release activities in support of the Production Department. They will manage and evaluate the members of the Raw Materials and Environmental Monitoring Group. The Manager of Quality Control also coordinates testing to be performed by other QC personnel and by contract laboratories. Additionally, this individual supports the Director of QC in reviewing data and reports. They also drive advances in analytical capabilities for raw material and environmental monitoring and works towards the development of group members.

Your Tasks

  • Manage all Raw Materials and Environmental Monitoring Group activities
  • Manage and execute raw materials scheduling and release activities including qualification, testing, and release of raw materials for use in manufacturing
  • Establishment and revision of specifications and sampling plans for raw materials
  • Supervise and guide members of the Raw Materials and Environmental Monitoring Group to meet deadlines tied to manufacturing schedules and to fulfill technical and compliance requirements
  • Development and optimization of new and existing analytical methods for qualification and release testing of raw materials
  • Coordination of stability program and testing to meet stability endpoints
  • Manage raw material release activities to meet deadlines tied to manufacturing schedules
  • Monitor analysts for water systems implementation, environmental monitoring and data trending in a timely manner
  • Write, review, and approve QC Standard Operating procedures (SOP's) as needed
  • Expand analytical capabilities of the Raw Materials and Environmental Monitoring Group
  • Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, environmental, and water testing
  • Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel who contribute to raw material release activities
  • Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent reoccurrences
  • Manage external test laboratories for contract testing of raw materials and other related testing
  • Review test data for completeness and accuracy
  • Provide timely responses to internal and external inquiries
  • Stay abreast of new developments in analytical technologies
  • Contribute to improvements in laboratory operations to increase efficiency and GMP compliance
  • Ability to work and communicate effectively with others within the company to ensure timely completion of tasks and projects


Your Profile

  • Ph.D. in Analytical Chemistry or related science field, or
  • Masters Degree in Analytical Chemistry or related science field and a minimum of 3 years of Stability/Raw Materials testing and GMP/GLP experience or
  • Bachelor's Degree with a minimum of 6 years of Stability/Raw Materials testing and GMP/GLP experience
  • Thorough knowledge and understanding of Analytical Chemistry, including USP materials testing
  • Extensive experience in cGMP laboratory testing
  • Provide technical support in water and environmental monitoring (TOC, pH, conductivity, bacterial endotoxin, HPC, etc.)
  • Hands on experience with HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, TOC, Bioburden, Bacterial Endotoxin, and MS
  • Methods development experience
  • Creativity to solve technical and compliance problems
  • Comply with good housekeeping and safety practices
  • Experience in writing standard operating procedures (SOP's) and test methods
  • Excellent written and oral communication skills
  • Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access
  • 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

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.

Nearest Major Market: San Diego