Temp-QC Scientist I

Description

• Lead Team in project Coordination and support
• Coordinate and support Tech Services Projects, which include:
  • Method Validations and optimizations
  • New technologies and equipment
• Assist in the identification of new testing technologies and equipment to meet evolving regulatory requirements.
• Support regulatory audits.
• Write protocols and execute method verification/validation/qualification/ transfers
• Write, execute laboratory investigations for out of specifications and out of trend results
• Point person for higher level meetings / projects such as CMC Team support.
• Write documents (SOPs, specifications, technical reports)
• Execute, oversee instrument qualification as necessary.
• Implement continuous improvement activities to maximize the resources available
• Write change controls and work orders for systems and instrumentation changes
• Review data as needed utilizing LIMS, SAP and SLIM
• Troubleshooting of technical procedures, methodology and instrumentation
• Data entry for testing results following GMP regulations
• Review tests results for other analysts
• Train new analysts and document training
• Provide technical support to new analysts
• Participate in non-routine projects, validations and method development to meet departmental and individual goals
• Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations
• Maintain the laboratory operations in compliance with industry regulations
• Maintaining inventory of material and reagents for technical services
• The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.

Qualifications

• BSc In science related field with (min) 10+ years experience in pharmaceutical manufacturing
• Able to work autonomously, receiving general instructions on new assignments.
• Strong technical knowledge of microbiological / Chemistry test instrumentation and method development / validation including software/computer system validation.
• Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters.
• Knowledge of current compendia requirements.
• Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor.
• Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations.
• Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally.
• Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances
• Good verbal and written communication skills; confident presenter, clear, concise technical writer.
• Familiar with common MS Office software packages.

Personal Attributes

• Motivated self-starter
• Team player
• Committed to quality
• Well organized, efficient worker
• Good problem solver
• Critical, analytical thinker
• Manages multiple duties and projects
• Creative, innovative thinker
• Easily adaptable to change
• Brings closure to work in a timely manner