Executing technical support activities for GMP Manufacturing Operations in a multi-product finishing CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Lead or execute implementation of targeted new technologies and procedures including development and deployment of new training initiatives.
- 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 secondary packaging issues and excursions, GMP lifecycle management of execution level process data, providing for unit operation (inspection, labeling, packaging)
- Perform machine set up, changeover, and troubleshooting and disperse knowledge by providing hands on training to line personnel
- Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.
- Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
- Work with Tech Transfer teams to transition products through the product development timeline
- Implement and review operational documentation systems within Finishing. Main responsibilities include authoring and implementation of manufacturing procedures and batch records. Drafting SOPs, addressing comments, incorporating edits and issuing final drafts for approval.
- Effectively collaborate with other team members, production operators, engineers, specialists, and senior management.
- Assist engineering and validation with implementation, commissioning, and validation of inspection and secondary packaging equipment.
- Take corrective action by thinking creatively, problem solving, and developing innovative solutions based on sound scientific analysis.
- Participate in client communications, including problem solving, schedule development, and project status updates as required
- Initiate revisions to cGMP procedures, and master batch records as applicable
- Willingness to maintain current on industry requirements and standards.
- Actively participate in Continuous Quality and Safety Improvements.
- 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
- Available for off-shift and/or on-call work, as needed.
- Independent worker and proven self-starter.
- Detail oriented.
- Professional and positive approach.
- Ability to follow procedures and regulatory guidance documents.
- Strong in building relationships and able to communicate at all levels.
- Team player, and able to work on own initiative.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must be mechanically inclined and have basic knowledge of semi-automated and fully automated high-speed packaging equipment functions.
- Experience with serialization and aggregation a plus.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Qualified candidates possess a Bachelor's degree in engineering, packaging technologies, or equivalent training and/or experience. Two to five (2-5) years of relevant experience in GMP packaging environment is required. Previous experience in a CMO and/or FDA regulated facility preferred.
GRAM supports Equal Opportunity Employment