Reviewer, Quality Control Documentation

Job Description

Job Description

Role Overview

The Quality Control Documentation Reviewer role is a position with responsibilities for supporting the document management process within a Quality department in Dietary Supplements to support commercial requirements, R&D support and validations in a GMP environment. This role will ensure compliance within the document management system, reviews, document storage and retention, and document issuance and reconciliation.

Areas of Responsibility

• Review of QC chemical lab chemist notebooks, Chromatograms, Calculation sheets, Raw Data Sheets and notebooks & labbooks for ICP
• Writing /Review/ update Standard Testing Procedures (STPs) / SOP for QC
• Supervision of QC Documentation associates and QC Documents writers
• Preparation/ Revision of RMS (Raw Material Specification) and FP specifications in coordination with QA
• Review of Instruments Logbooks & calibration notebooks
• Issuance of raw data sheets for QC Chemists for routine testing, if required
• Preparation of release certificates, if required
• Review of Outside Lab test reports for raw materials and finished products for accuracy as per USPL specification requirements
• Issuance and preparation of logbooks for QC Chemical / Microbiology / ICP-MS
• Review of monthly index of STPs, Stability samples, list of chemicals, reagents, reference standards, calibrations / annual PM of instruments, and maintain the records.
• Timely recovery of any records related to QC department requires at the time of GMP audit by any agency / customer
• Record keeping of QC related documents as per company policy and GMP requirement
• Good knowledge of FDA GMP guidelines for dietary supplements/ Drugs / Cosmetics
• Working as liaison between QC & QA
• review of stability documents stability protocols, reports and executed data of analytical lab and microbiology lab, if required
• Other responsibilities assigned by QC Director / QC Documentation Manager/ USPL Management

Other Responsibilities Including Safety:

• Works in a safe and responsible manner to create an injury-free and incident-free workplace.
• Complies with all job-related safety and other training requirements.
• Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

• BS/MS of Chemistry/ Science related qualification
• Knowledge of chemistry and 2 years minimum experience of working on chemistry lab instruments HPLC / UPLC, GC, UV-Vis spectrophotometer, Auto-titrators, Dissolution apparatus, strong knowledge of chromatography acquisition software system

Certifications, Licenses, Credentials:

• N/A

Skills & Ability

• Ability to maintain integrity and honesty at all times and to communicate with transparency.
• Ability to work independently or as part of a team.

• Strong working knowledge of Microsoft Word, Excel.
• Good documentation practices and able to write simple, clear reports
• Meets commitments on time and practices time-management skills

• Able to read, write and speak English fluently
• Knowledge of chemistry and 2 years minimum experience of working on chemistry lab instruments HPLC / UPLC, GC, UV-Vis spectrophotometer, Auto-titrators, Dissolution apparatus, strong knowledge of chromatography acquisition software system
• Must have strong experience of understanding and reviewing scientific data, excellent skills in computer software program of word, excel, pdf and access point, review of notebooks, calculations in excel / LIMS and QC related documents.
• Assure GMP compliance in documentation according to FDA cfr part 111 & GDP.

Physical Requirements (lifting, etc.):

• Ability to navigate office, lab, and/or plant floor working environments.
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.
• Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
• On occasion may need to lift up to 35 lbs.

Work Environment (Office, Warehouse, temperature extremes, etc.):

• Work is regularly performed in the office where temperatures are controlled, noise level is usually moderate, and area is without unpleasant or hazardous conditions.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

USPL is proud to be an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

Include shift schedule

English (US)

Office Hours: 8:30 AM - 5:00 PM / 9:00 AM - 5:30 PM