QC Manager BSD

Employer
Bachem
Location
Vista, CA, US
Posted
Sep 19, 2020
Ref
620800601
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
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 and

executes coordination and successful stability testing; raw material qualification, testing, and release

activities, as well as validation projects. The QC Manager 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. This role also serves to advance analytical capabilities and

contributes to the development of the QC department.



Your Tasks
  • Manage and oversee execution of QC testing including API, Raw material, validation, release, EM and microbial testing
  • Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
  • Establish and revise specifications and sampling plans for raw materials and final product
  • Develop and optimize of new and existing analytical methods for qualification and release testing
  • Coordinate stability program and the testing to meet stability endpoints, as needed
  • Manage raw material and API release activities to meet deadlines tied to manufacturing schedules
  • Write, review, and approve QC Standard Operating procedures (SOP's) as needed
  • Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
  • 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
  • Bachelor's Degree with a minimum of 5 years extensive industry experience
  • Thorough knowledge and understanding of Analytical Chemistry, including USP materials testing
  • Extensive experience in GMP laboratory testing such as HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.
  • Manage all method development activities, which include: Development and optimization of new and existing analytical methods for inĀ­ process control and QC release/stability and microbial and environmental testing
  • 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
  • Ability to drive projects to success under time constraints
  • Communicate effectively and ability to function well in a team environment


Preferred:
  • Ph.D. in Analytical Chemistry or related science field, or
  • Master's Degree in Analytical Chemistry or related science field and a minimum of 2 years of Stability/Raw Materials testing and GMP/GLP experience



We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

l 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