Responsible for executing technical support activities for GMP Manufacturing Operations in a multi-product, Fill/Finish CDMO facility. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance. This position will work closely with Quality as well as Operations, Continuous Improvement and Project Management to support site objectives.
ESSENTIAL DUTIES & RESPONSIBILITIES
Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of deviation investigations.
Ensures appropriate risk analysis, root cause and corrective action tools and identification is used for all deviation investigations.
Authors and revises site procedures in a timely manner to address CAPA and corrective actions for deviation investigation and/or site continuous improvement projects.
Assist implementations of targeted new technologies and procedures.
Assess, evaluate and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis and reporting.
Serve as first line of defense for all manufacturing excursions, GMP lifecycle management of execution level process data, providing for unit operation (formulation, sterile filling, inspection/labeling)
Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
Effective cross-functional collaboration with Quality, Continuous Improvement, MSAT, AMAs, Operations Supervision and Management.
Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment.
Take corrective action by thinking creatively and problem solving to develop innovative solutions based on sound scientific analysis.
Initiate revisions to cGMP procedures, and master batch records as applicable
Initiates daily, weekly and monthly site quality metrics and trend reviews.
Assists in the review and approval of Validation documents and site change controls.
Works an on-call schedule for technical supports and site deviation analysis.
Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
Support Agency, customer, and vendor audits as needed.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
Independent, self-starter that can work independently with excellent attendance.
Developed written and oral communication skills to facilitate detailed and thorough deviation investigations and follow-up with internal customers (e.g. Quality, Engineering, Maintenance).
Strong work ethic and flexibility to effectively respond to rapid changing work requirements and challenges.
Professional and positive approach.
Ability to follow procedures and regulatory guidance documents.
Willingness to work at multiple locations in the area and extended hours to meet business objectives.
Strong in building relationships at all levels and working in teams.
Proficiency in presenting information and data.
Energetic and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results oriented and efficient.
Creative, open-minded, and fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base and cross-functional team (internally and externally).
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Must have a strong skillset in root cause analysis, technical writing and CAPA in a GMP environment and/or related LEAN/six-sigma experience.
Qualified candidates have a Bachelor's degree in life sciences or equivalent training and/or experience. 4-5 years of relevant experience in pharmaceutical manufacturing is required. Previous experience in a CMO and sterile filling is preferred.
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