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Job Details:

Duration:** **12** **months** **contract

Top 3 Must Have Skill Sets:

+ Deviation Investigation Owner

+ Change Control Owner

+ Collaboration Skill

Description:

+ The ideal candidate will bring at least 1 year of industry experience within a GMP-regulated Biotech or pharmaceutical environment.

+ They must demonstrate strong knowledge of quality systems, QC laboratory operations, and manufacturing processes, with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.

+ This role requires excellent written communication, grammar, and investigative leadership skills.

+ Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight.

+ They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion.

+ Experience with Veeva Quality Systems is highly desirable.

Details:

+ This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

+ Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System

+ Individual will lead investigation teams and help to collect and report metrics for the systems team

+ Individual may assist with review of validation documents to support equipment and computerized system onboarding.

+ Individual may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.

+ Support the startup of a GMP QC laboratory.

+ Support routine activities over the weekends and public holidays as required.

Basic Qualifications

+ High school/GED + 2 years work experience OR​ Associates and 6 months work experience OR​ Bachelors

Day to Day Responsibilities:

+ Drive and manage all aspects of assigned deviation investigations from initiation to closure within QMS (Veeva), ensuring adherence to established timelines.

+ Author well-documented and scientifically sound investigation reports that clearly explain the event, the impact, and the corrective actions.

+ Conduct comprehensive root-cause analysis using standard industry tools (e.g., 5 Whys, 5M) to identify the root cause of quality events.

+ Develop, implement, and track effective CAPAs to prevent the recurrence of similar deviations.

+ Working collaboratively with Quality and Quality Assurance teams to author and own change control records

+ Ensure all change control documentation, including justifications, impact assessments, qualification/validation requirements, and implementation plans are completed accurately.

+ Manage change control records within QMS system (TrackWise or Veeva) and ensure timely review and closure.

+ Effective and Efficient communication with internal and external parties.

+ Excellent project management, organizational, communication, and problem-solving skills.

_About US Tech Solutions:_

_US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit_ _www.ustechsolutions.com_ _._

_US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran._