Description
The Quality Unit Business Process Specialist is responsible for quality oversight of SAP processes, business rules, and systems used and the inter-relatedness between each process, rule, or system in order to identify opportunities for improvement and to avoid conflict between processes and systems.
As a member of the Quality Assurance Operations, this position is co-responsible for the site and the department results. You will act as a Quality Unit Business Process Specialist supporting a United States manufacturing site. You will partner day-to-day with operations, engineering, IT and quality teams to design, implement and sustain quality processes that keep production compliant and reliable.
Responsibilities:
- Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.
- Key contact for internal departments and other sites for information and assessment and distribution regarding master data.
- Act as site Quality Consultant for SAP when issues arise.
- Act as Quality Assurance oversight of QC Master Data, ensuring adherence to procedures, policies, standards and FDA regulations.
- Demonstrated familiarity and compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
- Be SME for local SOPs where SAP is utilized as well as QA approver / compliance authority for QC SOPs relating to QC master data.
- Train users related to SAP business processes.
- Assist with QA Systems objects (including deviations, change controls and CAPA involving SAP use).
- Lead the design, documentation and maintenance of quality unit business processes and standard operating procedures.
- Work with cross-functional teams to translate operational and technical requirements into practical process controls.
- Support change control, risk assessments and quality impact evaluations for process and system changes.
- Contribute to investigations, root cause analysis and corrective and preventive actions to prevent recurrence.
- Monitor quality metrics and trends and recommend process improvements to reduce risk and improve performance.
Basic Qualifications:
- Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
- 3-5 years’ experience in cGMP production or quality control for cGMP manufacturing.
- 1-3 years’ experience designing or implementing business processes or SAP systems.
- Practical experience writing or maintaining procedures, work instructions, or process documentation.
- Strong verbal and written communication skills and ability to work on-site with cross-functional teams.
Preferred Qualifications:
- Experience in biologics or pharmaceutical manufacturing environments with computerized systems or digital manufacturing tools.
- Experience with risk assessment tools and verification of mitigation actions.
- Training or experience in structured root cause analysis methods.
- Proven ability to influence and coach colleagues across functions and levels.
Work Arrangements: This role is on-site at a United States manufacturing location. Regular presence in production and laboratory areas is required. Hybrid or remote work is not available for this position.