Associate, QA 2 - MFG & PKG

Job Description

Job Description

Date

06/2018

Location

1300 Airport Road, North Brunswick NJ

Title

Associate, Quality Assurance

Department

Quality Assurance

Reports to

Manager, Quality Assurance

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 110 and 111.

Areas of Responsibility

Understand and assist in maintaining compliance to FDA Regulations 21 CFR 110 and 111 for food and dietary supplements and other global food regulations as needed.

Execute the batch disposition process for raw materials, components, and finished products.

Lead investigations for quality related issues through non-conformance and deviation systems, CAPA process.

Interpret and implement quality assurance standards/SOPs effectively and accurately.

Mentor the Quality Specialist performing batch record review process.

Assist and/or lead internal audits and regulatory audits as directed by management.

Assist with equipment qualification and process validation as needed.

Provide oversight to the calibration process.

Provide oversight of the change control process.

Perform complaint investigations.

Gather, trend, and assess data and maintain metrics for Quality Assurance.

Train, support, and mentor QC Inspectors that assist in providing direct production oversight.

Other projects as directed by the QA Manager.

Meets all safety expectations and follows all safety practices.

Works extended hours and occasional weekend overtime.

Other duties as assigned

Other Responsibilities Including Safety:

N/A

Requirements

Education & Qualification:

Minimum of 3+ years of experience in a QA Inspector within a nutritional supplement, food, consumer products or pharmaceutical company.

BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.

Certifications, Licenses, Credentials:

N/A

Skills & Ability

Demonstrates ability to work in a team and assist others.

Able to follow written instructions precisely and perform basic math calculations as required.

Attention to detail and accuracy with numbers.

Understands and is knowledgeable of cGMP, OSHA standards etc.

Must be able to distinguish different shades of colors.

PC-based computing experience (Word, Excel)

Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP’s, GLP, documentation) when performing the assigned activity.

Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.

Physical Requirements (lifting, etc.):

Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.

Must stand and walk on production floor a minimum of 6 hours per shift

Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.

Occasionally works from a rolling ladder or step stool.

Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses.

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

Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.

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.