Work Location: Round Rock, Texas Shift: Department: LS-SC-PUKRDQ QCA
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Project Associate is responsible for assisting the Quality Control Management in oversight of operations within the Quality Control group. Responsibilities include leading or coordinating projects within safety, quality, scheduling, stability, metrics, regulatory and testing. Specific responsibilities include:
Coordinating the product shelf-life stability program including:
Scheduling of stability testing
Document preparation including protocols and summary reports
Routine coordination of QC testing to support production schedules including:
Testing and schedule entry into Quality Control Management System (QCMS)
Regular QC and cross-functional team communications for workflow prioritization to ensure testing meets lab goals and established timelines
Test plan and batch record creation and revision
Project management of:
Method, instrument and computer data system qualifications and validations
Lab advancement initiatives
Corrective Action Preventative Action (CAPA), deviation and change control
Coordinate completion of OOT and OOS investigations and actions
Review of product, raw material and custom analytical testing records for accuracy, completeness, and compliance for release to Quality Assurance review
Schedule production and stability projects for testing to avoid backorders and supply distribution This includes:
Timely scheduling of projects into QCMS in accordance with production and customer needs
Review and revision of test plans
Assigning appropriate due dates
Manage retest and stability program
Collaborating with QC management to develop QC strategies and plans to optimize group performance
Timely review of finished product and validation records
Coordinate thorough and timely completion of OOT and OOS investigations and associated action items
Identify quality issues and alerting management
Lead or coordinating special projects and initiatives to improve QC lab safety, production and quality
Performing other duties as assigned by the Lab Manager
Who You Are:
Basic Qualifications:
Bachelor's Degree in Chemistry, Chemical Engineering, or other Life Science discipline
2+ years of quality control experience
Preferred Qualifications:
Working knowledge of the ISO 9001, 17025 and 17034
Working knowledge of GxP (GLP/GMP)
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
