Manufacturing Specialist Deviation

Description:
SUMMARYWith minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
FUNCTIONSApplied Process Expertise1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.3. Provide troubleshooting support.4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Process Monitoring:1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.2. Provide support of timely execution of the process monitoring quarterly reports.
Non-Conformance and CAPA1. Ensure that all Non-conformances are triaged within the established goal.2. Responsible for authoring investigation reports.3. Responsible for execution of corrective actions.4. Responsible for managing NC/CAPA closure within established goal.5. Monitor and communicate incidents trends.6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Process Validation1. Assist with generation of process validation protocols and reports.2. Assist with the execution of the process validation.3. Support collection and analysis of process validation data.
Regulatory:1. May participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Change Control:1. Assist manufacturing change owner on CCRB packages impacting the process.
Projects and Initiatives:1. Participate on the assessment or implementation of special projects or initiatives.** Other functions may be assigned.
EDUCATION-Doctorate OR-Master’s + 2 years of Manufacturing Operations experience OR-Bachelors + 4 years of Manufacturing Operations experience OR-Associates + 8 years of Manufacturing Operations experience OR-High school/GED + 10 years of Manufacturing Operations experience.
COMPETENCIES/SKILLS-Detailed technical understanding of bioprocessing unit operations.-Skilled in performance of GMP production operations.-Regulatory knowledge and interactions.-Participate and help lead cross-functional teams.-Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.-Organizational, technical writing and presentation skills.-Basic project management skills.-Basic knowledge of control charting.
What attributes (i.e. - preferred qualifications) would make this candidate stand out?• Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.• Proficient and experienced in owning Change Controls.• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.• Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)• Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system• Experience navigating and executing transaction in SAP (ERP) system.• Ability to tactfully negotiate and positively influence peers and executive leadership.• Strong negotiation skills when working with external suppliers and internal team members.• Ability to maintain remote working relationships with colleagues and network.