Specialist (Formulation - GMP)

工作内容

Responsibilities

• Makes independent decisions regarding a product’s path based on individual attributes of the product and customer requirements
• Makes pass/fail determinations based on QC testing and customer requirements
• Documents procedures used for each product in custom software or by other controlled methods
• Identifies effectively, the need for documentation/process changes, process deviations, product non-conformances and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems
• Creates work instructions, standard operating procedures (SOP) and oligo master records (OMR) that meet customer requirements
• Adheres to customer specifics (in a strict manner) as well as general work instructions and SOPs
• Performs training on new procedures
• Troubleshoots and corrects problems that may occur during daily operations
• Collaborates with members of team, as well as management, to ensure open communication and teamwork
• Initiates PCOs when necessary for process and instrument changes
• Programs, uses and maintains equipment used in the departmental tasks and processes
• Participates in the validation of equipment used and processes performed in the group
• Investigates customer complaints and obtains data for customer inquiries
• Participates in customer and regulatory audits, as needed
• Assists in utilizing metrics to monitor and communicate TAT and error rate to lab and upper management
• Is aware of IDT’s policy on and contributes to quality and environmental management by adhering to the requirements of the ISO 9001, 13485 and 14001 standards and internal procedures and work instructions.
• Performs other duties as assigned.
  

Qualifications

• Associate’s degree in science related field plus 2 years of applicable lab experience required
• Bachelor’s degree in science related field preferred
• Proficiency in a variety of PC software programs with strong working knowledge of Microsoft Office (and an emphasis on Excel) required
• Proficiency with Excel, PowerPivot, JMP, or other statistical analysis software preferred.
• Proficiency with Word and PowerPoint preferred.
• Strong attention to detail
• Uses aids and SOPs and departmental knowledge to make decisions about the proper production path per product
• Ability to prioritize and organize workload to efficiently accomplish departmental goals
• Ability to work in a team environment as well as independently
• Ability to manage time and recognize responsibilities
• Ability to communicate with peers and all levels of management
• Ability to perform under stress when confronted with emergent, critical, unusual, or dangerous situations, or situation in which working speed and sustained attention are make-or-break aspects of the job.
• Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure.
• Ability to maintain both a high standard of courtesy and cooperation in dealing with co-workers.
• Ability to accept responsibility for the direction, control or planning of an activity.
• Adaptability to situations requiring the precise attainment of set limits, tolerances or standards.
• Ability to perform repetitive work or to perform continuously the same work, according to set procedures sequence or pace.
  

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Responsibilities

Makes independent decisions regarding a product’s path based on individual attributes of the product and customer requirements. Makes pass/fail determinations based on QC testing and customer requirements. Documents procedures used for each product in custom software or by other controlled methods. Identifies effectively, the need for documentation/process changes, process deviations, product non-conformances and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems. Creates work instructions, standard operating procedures (SOP) and oligo master records (OMR) that meet customer requirements. Adheres to customer specifics (in a strict manner) as well as general work instructions and SOPs. Performs training on new procedures. Troubleshoots and corrects problems that may occur during daily operations. Collaborates with members of team, as well as management, to ensure open communication and teamwork. Initiates PCOs when necessary for process and instrument changes. Programs, uses and maintains equipment used in the departmental tasks and processes. Participates in the validation of equipment used and processes performed in the group. Investigates customer complaints and obtains data for customer inquiries. Participates in customer and regulatory audits, as needed. Assists in utilizing metrics to monitor and communicate TAT and error rate to lab and upper management. Is aware of IDT’s policy on and contributes to quality and environmental management by adhering to the requirements of the ISO 9001, 13485 and 14001 standards and internal procedures and work instructions. Performs other duties as assigned. Uses aids and SOPs and departmental knowledge to make decisions about the proper production path per product. Ability to perform repetitive work or to perform continuously the same work, according to set procedures sequence or pace.