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Quality Control Lead - Master Data

Rentschler Biopharma, Inc.
Milford, MA
  • Expired: January 13, 2023. Applications are no longer accepted.
About The Company

Biomanufacturing Excellence at your doorstep - Meet Rentschler Biopharma in Milford!

Are you looking for purposeful position with a small, family-owned company where you are recognized for your work and control your own destiny? Please, come grow with us personally, professionally, and scientifically!

Rentschler Biopharma, headquartered in Laupheim, Germany, is a leading global contract development and manufacturing organization (CDMO), focused exclusively on client projects. Rentschler offers services for both process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Since expanding into the U.S. in 2019, Rentschler has grown its development & manufacturing capabilities and recently broke ground for its new, state-of-the-art production site in Milford, MA. Join us in the transformation of the Milford site to serve as a multi-client, multi-product CDMO facility.

Job Summary

The LIMS / Empower Master Data (MD) Builder arranges the creation and modification of LIMS / Empower master data specific to the Milford site. The MD builder will also provide support to customers to understand the requirements for updates or new master data. They will create and modify LIMS / Empower master data in accordance with global procedures and site change control.

Essential Duties and Responsibilities:
  • Processes changes of varying complexity to existing LIMS Master Data and Empower Enterprise
  • Creates new Master Data of varying technical complexity
  • Provide troubleshooting expertise and support for all LIMS and Empower activities and end users including instrument interfaces in conjunction with the IT Department
  • Aid in interfacing with site personnel on integration of sample management and electronic system processes to ensure optimal laboratory operations
  • Aid in providing hands-on, individual and group training(s) as needed for all user levels and develop training modules/protocols/walk-through guides accordingly
  • Aid in updating LIMS/ Empower and corresponding departmental SOP and training materials as needed in accordance with global procedures and processes.
  • Proactively analyze the data quality of maintained master data and take required action
  • Adapt, improve, and modify working methods to optimize for day-to-day processes and systems
  • Develop understanding of manufacturing processes to provide thorough review and feedback for new material templates that are submitted by Product Development
  • Analyze system data to identify data anomalies and work with business units to make the necessary corrections
  • Provides ad hoc reports as requested by various departments
  • Assists in streamlining Master Data procedures to increase efficiency as a continuous improvement effort
  • Performs other related duties and assists on assigned projects as required
  • Able to lead, coach and mentor others in consulting skills
  • Good understanding of the complexity, interactions, and dynamics within an international company
  • Working understanding of systems and how they interact
  • Serves as specialist in one master data area while learning others
  • Execute training and development activities for master data area
  • Experience with other QC lab software (i.e. CDS software + etc.) is a plus
    • OpenLab ChemStation
    • 32Karat
    • WinLab
    • SoftMax Pro

Qualifications:
  • BS in chemistry, biology or computer science preferred or relevant studies/applicable laboratory/software application experience required
  • Preferred experience in Lab Vantage LIMS and Empower software systems
  • Preferred experience in LIMS Basic Coding
  • Preferred experience in Application Lifecycle Management Quality Center (ALM-QC)
  • Excellent knowledge of Microsoft Office
  • Well organized, able to work on multiple projects
  • Able to effectively work independently or within a team environment
  • Demonstrate attention to detail
  • Excellent oral and written communication skills


Frequent Contacts:

Internal
  • Department leaders and scientists
  • Leadership team
  • Supervisors
  • Project leads


Other Job Requirements:
  • Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
  • Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines.
  • Thorough knowledge of regulatory issues and the impacts on discipline.
  • Strong knowledge of general cGLP procedures and those specific to discipline.
  • Strong MS Excel, PowerPoint, and Word skills. Microsoft Project skills preferred.
  • Excellent organization and planning skills.
  • Strong attention to detail and ability to adhere to standards procedures.
  • Ability to drive functional, technical, and operational excellence.

What's in it for you?
  • Small, growing family run company with lots of opportunity for growth
  • Competitive compensation & benefit package to include major medical/dental/vision
  • 401k plan with a generous company matches with no vesting period
  • Three (3) weeks paid vacation plus company-paid shut down the last week of the calendar year
  • $10,000 in tuition reimbursement annually
  • Group life insurance, STD/LTD plans
  • Plus, great, interesting, career-minded professionals to work with every day

Rentschler Biopharma, Inc.

Address

Milford, MA
01757 USA

Industry

Business

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