Quality Assurance Data Review Scientist

Cambrex High Point • High Point, NC • 3h ago

Company Information

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 over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Job Overview

Come join our QA team of experts. The Data Review Scientist conducts data review activities for data generated by GMP Analytical for validation of analytical test methods, testing of cleaning samples, raw materials, process intermediates, final APIs, and final dosage forms, characterizing/qualifying Reference Standards, and Stability results. These data reviews are accomplished by review and approval of GMP Analytical Laboratory data located in notebooks, Material Release Forms, stability reports, methods qualifications/validations and reports, etc., as well as other documents as assigned.

Responsibilities

Reviews chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, SOPs, and Good Manufacturing Practices (GMP).

Must be able to understand analytical data (chromatographic and other) and scrutinize routine and non-routine testing results to ensure compliance, accuracy, and completeness of work based on documented data.

Must be able to critically and in detailed fashion review/verify Reports, SOPs, Specifications, Analytical procedures, etc. Example: Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.

Must be able to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

Must be able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Organizes workflow and tasks to maximize efficiency (e.g., prioritize review/writing based on client/business needs, etc.).

Demonstrated ability to work with others at all levels of the organization and have basic knowledge of computers and industry-related software.

Ability to work effectively under pressure to meet deadlines.

Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines.

Qualifications/Skills

Fundamental understanding (experience is not required) with the following analytical technologies:

Titrations (manual and automated)

Basic wet chemistry

FTIR

NMR

XRPD

DSC

HPLC

Working knowledge of other analytical equipment common to the pharmaceutical industry.

Education, Experience & Licensing Requirements

BS or MS in Chemistry (or closely related discipline). Relevant background in GXP/QC-compliant pharmaceutical laboratory environment.

Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.

Demonstrated ability to work in a diverse team environment.

Proficiency with Microsoft software (Word, Excel and PowerPoint).

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.

LI-RD1

Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals.

Position also requires visual acuity, talking, and fingering.

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