Program Manager - Quality Control Systems

Employer
Bachem
Location
Vista, CA, US
Posted
Nov 10, 2020
Ref
631557701
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Program Manager fulfills a critical role for the site Quality organizations at both our Torrance and Vista sites. This individual will be responsible for assisting with the development / harmonization of Quality Control Systems at Bachem US sites and subsequent maintenance and oversight of these systems. This position will collaborate with QA, QC, QE and other team members at sites in the US and Europe to implement and maintain quality control laboratory related data base software solutions e.g. Laboratory Information Management Systems (LIMS), Chromatography Data System (Chromeleon) and LabX. This position will also apply laboratory knowledge and expertise to lead requirements gathering, definition, design, development, configuration and implementation (including training personnel) of new laboratory software solutions.

Your Tasks:

  • Assist with the development and harmonization of quality control (QC) software systems at BTO (Torrance site) and BSD (Vista site) and subsequent maintenance and oversight of these systems e.g. Laboratory Information Management System (LIMS), Chromatography Data System (Chromeleon) and LabX
  • Assist and lead software implementation projects in the QC units at BTO and BSD
  • Collaborate with QC, QA, QE, IT and other team members at BAM and BEU to define, design, select, develop, configure and implement QC laboratory related software solutions based on predefined user requirements
  • Assist with computerized systems validation and software life cycle management/change management of new and already established QC laboratory software solutions at BTO and BSD
  • Configuration, set-up and maintenance o f analytical master data in QC laboratory software systems e. g. methods, workflows, specifications, test plans, sampling plans, report templates, generic calculations, etc.
  • Ensure availability of required master data to support day-to-day QC operations at BTO and BSD
  • Creation of QC laboratory software systems related documents e.g. SOPs, working instructions, training documents, manuals
  • Actively participate in the education and training of personnel (i.e. QC, QA, Mfg., etc.) regarding functionality and utilization of laboratory software systems
  • Create and refine training plans, implement additional training (documents) for internal personnel as required


Your Profile:

  • BS degree in a science discipline - Chemistry, Biology, Information Technology (IT) or equivalent.
  • Minimum of 5 to 8 years of experience in QC and/or IT.
  • Extensive experience in cGMP manufacturing or Quality Control environments.
  • Solid knowledge base in laboratory information systems.
  • Experience with Software Development Lifecycle (SDLC) management, Computerized Systems Validation (CSV) and Qualification, Administration of regulated applications, Change Management (master data and configuration management).
  • Experience in writing standard operating procedures, specifications, validation protocols and reports and technical reports.
  • Good working knowledge of Microsoft Office programs (Word, Excel, Powerpoint etc.)
  • Strong interpersonal communication skills, written and verbal. Able to work effectively with various technical levels and maintain a high level of professionalism when working with peers, internal and external stakeholders, auditors and inspectors.
  • Proven ability to design clear processes and detailed yet flexible approach to problem solving.
  • Strong time management/organization skills with the ability to effectively manage competing priorities. Ability to manage multiple simultaneous projects and initiatives.
  • Self-motivated individual with a record for achievement through past industry experience.
  • Excellent problem solving capabilities and judgment; ability to make sound decisions independently, solutions oriented, business approach.


Preferred:

  • MS degree in Science discipline.
  • Experience with LIMS and other laboratory software solutions e.g. Chromatography Data Systems.

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