TECHNICAL WRITER ANALYTICAL METHOD VALIDATION

Regular
16 Elkins, East Brunswick
Posted 1 week ago

Job Summary:

This person currently in this position in AMV is primarily responsible to gather data/results from AMV studies and present in a technical report for submission. Additionally, he is also given the responsibility for assisting in ordering chemicals, standards, and Lab consumables for the AMV group. The person is also responsible to organize and store written protocols, reports, folders with chromatograms/ UV spectrums, and books in an orderly fashion and archive with the QA group as needed for the AMV group.

Reporting Relationships:
•    This position directly reports to the Associate Manager/Manager of AMV and in-conjunction with the Director for AMV.

Essential Functions:
•    The position includes Over-seeing of the following activities but not limited to:
o    Prepare Analytical Method Validation/Verification/Transfer Reports for method validation group per written procedures and cGMP Guidelines.
o    Be able to review Written Technical Protocols and Methods for Method Validation Studies.
o    Assist method validation department for general tasks including ordering of chemicals, HPLC accessories and other Consumables for the AMV group.
o    As needed perform additional duties for Quality Control (AMV) Department.
o    Upkeep the AMV group with respect to organizing and storing written protocols, reports, folders with chromatograms/ UV spectrums and books in orderly fashion and archive with the QA group as needed for the AMV group.

Specialized Skills and Knowledge:    
•    Minimum BS in Chemistry or related field. Computer knowledge for executing Words, Excel is mandatory. Report Writing Experience will be considered as a plus.
•    Prepare and review documentation (reports and other relevant doc.) on new product development with respect to Quality Control, Method Validation and R&D. Critic and corrects the reports as needed with feedback from Associate Manager/Associate Director AMV. Should be able to review protocols.
•    Conducts literature searches for new method development projects (AR&D) utilizing chemical, medical, analytical and scientific abstracts.
•    Requires knowledge of product areas, current developments and keeping update of current literature.
•    Preparation of analytical documents (Reports) for regulatory submission for FDA deficiencies, Transfer products and Development projects in conjunction with upper management.
•    Collects and maintains product documentation files & folders, Guidelines and Literatures.
•    Understands and applies USP monographs & general chapters.
•    All other job-related duties with respect to ordering of Chemicals, HPLC Accessories,
Consumables, etc. for the AMV department.

Key Competencies:
•    Basic Knowledge of a variety of laboratory instruments including many of the following: HPLC, UV/Vis spectrophotometer, pH meter, analytical balances, moistures, hardness friability.
•    Understands and uses good quantitative techniques in performing analytical tests calculations.
•    Computer skills for data processing/storage.
•    Has the ability to understand and follow written methodologies in accordance with cGMP standards

Physical Demands/Factors:
While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.

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.


Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Job Features

Job CategoryQuality Control

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