![Advanced Recruiting Partners](https://scienceabode.com/wp-content/plugins/wp-job-manager/assets/images/company.png)
Website Advanced Recruiting Partners
Advanced Recruiting Partners
Company : Advanced Recruiting Partners
Job description
Key responsibilities in QC Method Transfer and Validation are performing tasks/activities associated with analytical method qualification, validation, verification and transfer. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer to support Pharmaceutical’s quality programs. You will be responsible for participating in laboratories’ readiness for routine testing of but not limited to, Demo, Engineering, CTM (Clinical Trial Material), product/process validation and commercial batches manufactured at Pharmaceutical. Additional responsibilities will include driving continuous improvement/Operational Excellence/innovative implementations; represent QC MTV on cross functional teams; and providing guidance/training/coaching to junior colleagues; troubleshooting.
Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely
Recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pharmaceutical policy and standards • excellent effective written and verbal communication and interpersonal skills; established relationships within business lines
Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues
Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals
Solving highly complex mathematical problems and situation dependent problems using convoluted information
Method 1, yellow belt trained and can apply tools to solve issues (including technical issues)
Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior
Good judgment and correct decision making based on Pharmaceutical procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network
Represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements
Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule
Delivery on high business impact projects/activities/changes
Able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations
Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations
Able to identify and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues
Displays strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation
Expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft OfficeTM applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Qualifications
Bachelor’s Degree –
5-7 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph.D. in Science/related field
Demonstrated experience in Quality Control
Good knowledge of analytical method validation
Good knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
Reasoning ability including strong analytical and problem-solving abilities
Strong verbal and written communication skills Nice-to-Have
Master’s degree –
Experience with a wide range of analytical techniques, analytical testing and use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, PCR, plate-based assays, IEF, etc
Experience in Analytical method validation and transfer
Experience supporting Change Control Assessments
Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.
#IND