Cambrex
Technical Reviewer
US-CO-Longmont
Job ID: 2024-3682
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - Longmont
Overview
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.
Responsibilities- 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
- Reviews technical documents such as protocols and technical reports for qualification/validation and stability activities, as required
- Works 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
- Escalates issues which may impact timeline to laboratory and quality management
- Ensures 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
Qualifications- BA/BS in Life sciences field is required
- 4+ years of relevant experience in a CDMO and/or pharmaceutical environment
- Experience in laboratory testing, preferably in the pharmaceutical or biotechnology industries
The hiring range in Colorado for this position is $82,000 - $94,000/ year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity, and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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