Soft Skills:
- Engaging team player, with a perpetual “positive spin”.
- Responsive professional, able to prioritize workload, manage multiple tasks and adapt to the changing needs of the company.
- Keen attention to detail.
- Excellent organizational and communication skills.
- Creative “outside the box” thinker with a resourceful mindset.
- Effective problem solver and decision maker.
- A self-motivator who readily “rolls up her sleeves”.
- Continuously increasing skills and knowledge.Totally dedicated to helping the company to obtain extraordinary performance in research, manufacturing and marketing.
Project
Coordination:
- Initiate and maintain project administration processes and
documentation.
- Monitor, evaluate and communicate project schedules.
- Implement
constructive ideas.Interface with multidisciplinary internal departments and
external vendors.
- Proficient with most computer software, especially Microsoft
Office and Windows applications.
Research, Development, Quality Control:
- Demonstrate knowledge of scientific principles in a GMP/GLP regulated environment.
- Possess comprehensive research and QC techniques: Analytical Chemistry, Immunology, Microbiology, Molecular Biology, Animal husbandry and research.
- Able to work with precision and understanding of the theory behind the experiments and protocols.
- Participate in the investigation, creation, development and validation of assays and test methods.
- Solid writing skills for preparation of technical reports, summaries, protocols, and quantitative analyses.
- Calculate, analyze and summarize data using basic statistics.
- Organize and maintain a functioning research laboratory.
Quality Assurance:
- Understand and apply quality systems, regulatory requirements and industry best practices.
- Assist with development and implementation of quality systems and procedures.
- Participate in internal and external client audit programs.
- Participate in product investigations to identify issues, root cause and corrective action plans.
- Create and edit technical documents ensure compliance with cGxPs and with correct formatting and style.
- Review documents for accuracy, traceability and completeness. Work with personnel to correct any noted deficiencies/inconsistencies.
- Manage and archive controlled documents.Assist with development and maintenance of spreadsheets and databases.
Customer Technical Support:
- Utilize product knowledge to match the needs of customers.
- Build relationships with customers and purchasing agents.
Validation:
- Create and execute protocols.
- Review data and records.Write final reports.
Manufacturing:
- Develop and execute Class 100 cleaning procedures.
- Investigate and purchase Class 100 cleaning equipment and materials.
- Collaborate with internal teams to resolve equipment and filter issues and develop quality control chemical test specifications for cleaning reagents.
- Collaborate with QC Microbiology to validate sterility of filtered cleaning reagents.
Supervision:
- Supervise, train, mentor and assist staff.
- Interview and provide performance appraisals for direct report staff.
- Review production/manufacturing reports completion and accuracy.
- Investigate and order supplies.
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