What are the responsibilities and job description for the Temp-QC Scientist I position at Alkermes?
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
- 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