Job Description
Date | 02/2021 | Location | 1200 Airport Road, North Brunswick NJ |
Title | Associate, Quality Control Documentation | Department | Quality Control |
Reports to | Manager, QC Documentation | FLSA (Exempt or Non-Exempt | Non-Exempt |
Role Overview |
The Associate, QC Documentation 1 primary responsibility is to coordinate within QC and with other departments to create, revise and manage technical and regulatory documents for raw materials efficiently and accurately. This position provides project/study and investigation support through review and technical writing of GMP documents (e.g., study specific protocols or validation reports), SOPs and other documents associated within QC area of responsibility. Additionally, the Associate will ensure the quality of laboratory data and reports and provide document coordination. |
Areas of Responsibility |
- Writes stability protocols / reports for samples
- Reviews various microbiology related documents like notebooks, receiving logs, calibration reports, and calibration books
- Prepares & reviews microbial CoA’s and reports
- Performs microbial testing when required, instrument, calibrations, and swab samplings
- Maintains & keeps records as per GMP
- Writes and reviews /updates QC SOPs and STPs
- Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity.
- Performs Quality Control (QC) checks on supplier’s CoAs vs RMS requirements, third-party testing data and test required/ results for conformance to both normative and client specifications where applicable.
- Communicates with QA regarding third-party testing reports availabilities and discrepancies
- Interpret and communicate test results intra department including any associated normative in RMS/CoA generation.
- Reviews, verifies and approves of Internal QC Instruments calibration / qualification.
- Engages in customer service interactions by electronic, telephone, and/or direct in-person correspondence pertaining to Calibrations, Annual PM and repairs
- Act as liaison between Research and Development and the Quality Control Lab to ensure specifications and test methods are completed fully and according to priority
- GRN updates on Syspro related to PO placed for QC
- Must be able to work extended hours as needed and occasional weekends.
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 in Chemistry or related scientific disciplines
- 2+ years of technical writing
- Minimum of 3+ years QC lab work experience with industry experience in dietary supplements, food or OTC manufacturing.
Certifications, Licenses, Credentials: Skills & Ability - Demonstrate strong command of English written and spoken language skills
- Possesses advanced MS Office software and have excellent typing skills
- Able to communicate corporate compliance issues to department heads
- Able to maintain professional and positive attitude
- Able to manage multiple tasks effectively & efficiently
- Possess high-level of ethics and integrity
- Must be able to keep information confidential
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.
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.
