QC Manager Technical Services, site based, Redmond, WA

QC Manager - Technical Services (Weekends Friday Saturday Sunday and Monday 4 x 10 hrs)

About Us: this is who we are

At Just Evotec Biologic we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

Were looking for a passionate and curious QC Manager to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a QC Manager at Just Evotec Biologic youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

Responsible for the weekend oversight for Quality Control lab operations at the GMP manufacturing facilities in Redmond WA and Seattle WA. This position supports routine GMP operations equipment qualification sample management and method lifecycle activities at Just-Evotec. Responsibilities include in-process and drug substance sample receipt and testing training of laboratory staff GMP document authoring / revision equipment maintenance providing oversight in support of GMP operations and spearheading initiatives to build infrastructure and processes across both Washington state facilities.

What Youll Do:

• Provide hands-on leadership for the weekend QC lab operations; management of daily/weekly/monthly activities of staff and operational oversight of group data review schedule and training.

• Oversee multiple QC analysts and direct management of individuals including goal setting performance feedback skills development and mentoring.

• Lead and provide guidance for QC testing and method qualification in support of GMP Biologics manufacturing including in-process stability drug substance and drug product release testing by various analytical and microbiological techniques.

• Collaborate cross-functionally to generate and approve protocols reports and other technical documents for the qualification of equipment and methods.

• Manage equipment onboarding qualification and maintenance for all QC instruments.

• Collaborate with Quality Assurance Manufacturing Material Management and other functions to ensure internal timelines sample receipt/testing TAT and team milestones are achieved.

• Oversee laboratory investigations deviations OOS change controls and CAPAs

• Create maintain and revise QC SOPs methods and associated documents.

• Manage all aspects of the weekend lab operations including the ordering supplies and maintaining laboratory equipment and lab spaces.

• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on QC related matters.

• Establish and publish Key Performance Indicators (KPI) to track cGMP compliance with testing and equipment procedures. Capture metric information for use in continuous improvement of areas of responsibility.

• Participate in daily and weekly operation meetings and Quality Management Reviews.

Who You Are:

• BS in biochemistry biology microbiology or chemistry with a minimum of 5 years of relevant experience within the pharmaceutical industry and a minimum of 3 years of hands-on industry experience managing a cGMP QC laboratory.

• Direct leadership experience .

• Experience in the validation and transfer of release methods and verification of compendial methods.

• Knowledge of regulatory requirements and guidelines (ICH CFR FDA) as they relate to drug substance biological manufacturing and release / stability testing / method validation.