Job Description

Job Summary

Performs critical in-depth review of all scientific data for Quality Control laboratory documents under minimal supervision.

Area Of Responsibility

With minimal direction from management, this individual:

• Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.

• Demonstrates a thorough knowledge of approved SOPs, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.

• Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.

• Supports systems to ensure the successful completion of Departmental goals and objectives.

Work Conditions:

• Office Environment

• Lab Environment

Physical Requirements:

• While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to visit lab environment, stand, and stoop, kneel and crouch specific vision abilities required of this job include close vision, distance vision, color vision and the ability to adjust focus.

• The employee must regularly lift and/or move up to 10 pounds.

Travel Estimate

Up to 0 %

Education and Job Qualification

• Minimum of a Bachelors.

• Extensive knowledge of pharmaceutical analysis.

• Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.

• Good understanding of EHS and OSHA safety guidelines.

• Extensive knowledge of USP, ICH, FDA, and DEA regulations.

• Extensive knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.

• Demonstrated excellent communication: verbal, written and presentation skills.

• A self-starter with a hands-on approach and a can-do attitude.

• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum of six (6) years of experience in a pharmaceutical environment with a minimum four (4) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

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