Associate, In-Process QA, MG/PG

1 month ago

East Brunswick, United States US Pharma Lab Full time
Job Description

Date

04/2018

Location

1300 Airport Road, North Brunswick NJ 08902

Title

Associate, In-Process QA MG/PG

Department

Quality Assurance

Reports to

Quality Assurance Manager

FLSA (Exempt or Non-Exempt

Non-Exempt

Role Overview

The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements. Performs in-process quality testing in manufacturing (Standard and Probiotics) and/or packaging areas according to prescribed timelines, and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action.

Areas of Responsibility
  • Manufacture Production batches according to Batch Records, SOP's, and cGMP guidelines to ensure product specifications and tolerances are met.
  • Reads and understands approved specifications/standards assigned to the project
  • Directs personnel assigned to the specific production line, concerning the quality attributes to be adhered to and monitors the attire of personnel for adherence to cGMPs.
  • Determines the need and executes the halting of operations due to adverse quality conditions in an effective and timely manner.
  • Performs final review and approval of line clearance activities.
  • Collects and inspects samples as required; inspects product for correctness, performs weight checks, torque checks, vacuum chamber tests, lot code resistance testing, collects retain samples and packages and documents as required, etc.
  • At the assembly lines conduct quality inspections, including but not limited to inspection of the assembly line for cleanliness, use of correct components, use of correct labels, including correct label placement, condition of components and labels, overall product quality and cleanliness, use of correct lot code methodology
  • Performs in-process quality testing in manufacturing and/or packaging areas according to prescribed timelines, and accurately captures test results in batch records.
  • Objectively reviews, audits, and monitors the processes for adherence to quality, cGMP, and product specification standards from the time a production run starts-up, though to its completion against approved quality document or record.
  • Performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's
  • Communicates with Management, Production, and Planning regarding questionable measurements, non-conformance issues, consistency, and overall product quality.
  • Consistently records quality related results in accordance with prescribed good documentation practices requirements and data is accurately reported.
  • Visually verifies the completion of all steps in-process and strictly adheres to company policies and procedures
  • Cleans up work following the completion of a shift.
  • 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
Other Responsibilities Including Safety:
  • Works in a safe and responsible manner to create an injury-free and incident-free workplace.
  • Comply with all job-related safety and other training requirements.
  • Keeps management informed of area activities and of any significant problems.
Requirements

Education & Qualification:
  • Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company.
  • Or equivalent combination of education and experience.
  • High School diploma is required; 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, 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 35 lbs.; occasionally lift and move up to 50 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 and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees 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.

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