QC Scientist; pharma​/micro

Overview

Base pay range

$45.00/hr - $55.00/hr

Direct message the job poster from Astrix

Scientific and technical staffing leader connecting top talent with industry-leading companies

• 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

• BSc in a science-related field with (min) 10+ years’ experience in pharmaceutical manufacturing, MS degree with 3-5+ years of experience or PhD with 0-5+ years
• 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

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

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

• Mid-Senior level

• Contract

• Quality Assurance
• Industries
• Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

401(k)

Vision insurance

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