Role Name: QC Senior Associate (Level 4) – 12 month
Role purpose: QC Senior Analyst (QC NPI)
• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site projects
• Plan and Perform non-core testing related to NPI activities
• Manage all sample management activities related to NPI activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities for NPI activities
• LIMS data coordination of non-core ( NPI) activities.
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team
This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance.
May contribute to regulatory filings.
• May represent the department/organization on various teams. May train others.
• May interact with outside resources.
Primary knowledge, skills, competencies and relevant experience
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Communication skills (verbal and written) at all levels
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
• Decision Making skills
• Teamwork and Coaching others
• Negotiation and Influence skills
• Investigation skills
• Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
• Project Management and organizational skills, including ability to follow assignments through to completion
• Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project time-frames and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies
• Bachelor’s degree in a Science related field is required.
• 5+ years of bio/pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.