Technical Reviewer

1 week ago

Durham, United States Cambrex Full time
Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job 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. 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.
Qualifications/Skills

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 & Licensing Requirements

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.

Supervision Received: General Supervision
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: Not Applicable

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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