Technical Reviewer - Cambrex

The Technical Reviewer will work independently to provide a technical review for small and large molecule development and testing data in compliance with cGMP/cGLP standards and FDA / EU regulations. This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed within the specified timeframes. Ability to work within a dynamic and fast paced environment.

• Responsible for performing an independent technical review of all analytical (small and large molecule entities) GxP testing performed on starting materials, raw materials, intermediates, drug substance, drug product, packaging components, customer samples, stability study samples, in-process testing/checks, etc. for completeness, accuracy and compliance.
• Good understanding of analytical laboratory practices and able to apply quality assurance principles to the review process to ensure data is scientifically sound and compliant with all regulatory body requirements and local procedures.
• Review technical documents such as protocols and technical reports for qualification/validation and stability activities, as required.
• Work with analyst and laboratory management to conduct and document laboratory investigations.
• Provides accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates.
• Escalate issues which may impact timeline to laboratory and quality management.
• Ensure all issues/documentation is complete prior to approval.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Good interpersonal skills and willing to ask questions about procedures and concepts.
• Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs.
• Able to be trained.
• Effectively resolves quality issues and concerns in a timely manner.
• Effectively coordinates and organizes tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency.
• Creates strong and effective working relationships with Quality team, colleagues, and clients.

Required Knowledge/ Skills/Abilities
Knowledge

• Attention to detail, as well as time and resource management.
• Personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
• Promote a safe environment for work.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Strong knowledge and understanding of LIMS and Empower.
• Skilled in MasterControl, Trackwise and/or other QMS software applications, preferred.
• Strong knowledge and experience with a wide variety of analytical techniques such as HPLC, GC, FT-IR, ICP, NIR, UV/Vis, Karl Fischer, Total Particle Counters, required.
• Good understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.
• Understanding of microbes (e.g., bacteria, viruses, and fungi) and molecular assays, preferred.
• Knowledge of Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable), Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates) and/or Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host), preferred.

Skills / Abilities:

• Demonstrate the capability for continued upward growth and technical contributions.
• Good analytical and problem-solving skills with proven ability to think critically and to focus on details of execution.
• Good understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry
• Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
• Experience in trending analytical data (method data and product data) is preferred.
• Experience in trending environmental monitoring/clean room services data is preferred.
• Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred.
• Good technical writing skills. Experience authoring and reviewing technical documents such as reports and protocols.
• Strong Computer Skills
• Microsoft Suite, proficiency

Education & Experience
• BA/BS in Life science, required.
• 4+ years of relevant experience in a CDMO and/or pharmaceutical environment.
• Experience in laboratory testing, preferably in pharma or biotech.