Work Location: Round Rock, Texas
Shift:
Department: LS-SC-PUKO4 Ops Catalogue
Hiring Manager: James Kiesow
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Project Specialist, Manufacturing Support is responsible for evaluating new technologies and manufacturing processes for Round Rock catalog and private label customer-specific product formulations and aliquots. Specific responsibilities include:
- Execute and complete projects as designed and documented to produce finished products and meet production goals.
- Work with Team Leads to develop training programs that cultivate best practices to ensure the production of the highest quality reference standards.
- Write or revise technical documents such as batch records, procedures, and reports.
- Assist in evaluating problematic formulations or workflows, ensuring on-time project completion, communicating any delays, and ensuring work is performed according to MilliporeSigma Quality and Safety policies and good housekeeping practices.
- Coordinate production schedules using in-depth knowledge of project requirements.
- Evaluate new technologies and participate in new product design.
- Assist in writing technical documents such as batch records, forms, procedures, and reports.
- Assist in the review and resolution of non-conforming work or deviations from MilliporeSigma standard operating procedures and practices, including writing corrective and preventive action reports.
- Assist in training technicians on general quality documentation practices, project initiations, laboratory maintenance, and how to safely and efficiently operate laboratory equipment.
- Critically assess the team’s performance against production schedules and drive process improvement.
- Develop and schedule formulation workshops, open observations, proficiency events, and training video content.
- Serve as a designee for the Laboratory Manager in the approval of controlled production records.
- Order manufacturing raw materials for weekly scheduling based on the moved-to-standards folder published weekly and determine material availability.
- Perform specified manufacturing processes as designed and documented to produce finished products to meet production goals.
- Serve as a Project Lead and/or point-of-contact for specific projects as assigned by the Supervisor, including:
- Coordinate project-specific meetings to communicate project details to team members so that the group understands requirements and deadlines.
- Ensure that work is executed correctly, in compliance with customer requirements, MilliporeSigma Quality and Safety policies, good housekeeping practices, and is performed in a timely manner.
- Ensure that the materials required for specific projects are ordered, accounted for, and appropriately staged to support project deadlines.
- Ensure that the Laboratory is maintained in a state of “audit readiness,” including a clean and organized work environment, free of clutter, trash, chemicals, and materials that are not in use.
Who You Are:
Minimum Qualifications:
- Associate degree in Chemistry, Biology, or other Life Science Discipline
- 5+ years of work experience in a life science manufacturing environment
OR
- Bachelor's degree in Chemistry, Biology, or other Life Science Discipline
- 3+ years of work experience in a life science manufacturing environment
Preferred Qualifications:
- Understanding of Round Rock and customer products, their applications, and requirements
- Understanding of MilliporeSigma quality system requirements for GMPs, GLPs, ISO, and other regulations
- Knowledge of departmental goals, interdepartmental processes, and overall MilliporeSigma objectives
- Excellent attention to detail
- Strong verbal, written, problem-solving, and computer skills
- Ability to write technical documents such as batch records, procedures, and reports
- Ability to adhere to the six corporate MilliporeSigma values and display role model behavior based on these values
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.