Overview
Engineer II-Quality Jobs in Beverly, MA at Microchip Technology
Job Description
Date
03/2023
Location
1300 Airport Road, North Brunswick NJ
Title
Lead, Quality Assurance Operation Support
Department
Quality Assurance
Reports to
Manager, Quality Assurance / VP of QA
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The Lead Quality Assurance Operation Support performs line inspections as part of the cGMP’s, SOPs, and policy compliance requirements. Supervises in-process quality testing in manufacturing and / or packaging areas according to the prescribed timelines and accurately captures test results in batch records. The Lead performs calibrations and measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP’s. Technical writing of validation documents and review of executed validation batch records as per protocol and project requirements. Lead QA is a highly organized, self-starter who can work independently, demonstrates a positive attitude, and a bias for action.
This position Reports to the Quality Assurance Manager and dotted line to VP of Quality Assurance.
This position will help ensure compliance to SOPs, batch records, GMP documentation and to 21 CFR Part 111 and 117.
Areas of Responsibility
Ensure product specifications and tolerances are met according to the Batch Records, SOP’s, cGMP’s guidelines for Manufacturing and/or Packaging production batches.
Reads and understands approved specifications/standards assigned to the project.
Performs Line Clearance, and Inspection checks in dispensing, manufacturing, coating, and packaging areas.
Supervises in-process quality testing in manufacturing and/or packaging areas according to the prescribed timelines and accurately captures test results on the batch records.
Lead QA directs personnel to the assigned production line.
Ensures the adherence of quality attributes within the Packaging and Manufacturing work rooms and lines and monitors the attire of personnel as per the cGMP’s.
Notifies departments Supervisors, Line Leaders, and operators when operations must be terminated due to non-conforming quality conditions.
Communicate promptly and professionally with all levels of personnels.
Collects retained samples, packages and documents as required. Perform weight, and torque checks, vacuum chamber tests, and lot code resistance testing,
Conducts inspection of assembly line for cleanliness, accurate selection and condition of components and labels and correct use of label placement and lot code methodology, and overall product quality.
Objectively reviews, audits, and monitors the processes for adherence to quality, cGMP’s, and product specification standards from the time a production run starts-up, to its completion in accordance with the approved quality document or record.
Performs calibrations and measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP’s.
Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Validation Summary Report , IQ/OQ/PQ ), SOPs, Maintenance Procedures, Calibration Procedures..
Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
Consistently and accurately records and reports quality related data in accordance with good documentation practices.
Visually verifies the completion of all steps in-process and strictly adheres to company policies and procedures.
Responsible for the Issuance, execution, and review of Batch records.
Reviews AQL inspections for product release.
Works extended hours and occasional weekend overtime.
Other duties as assigned.
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:
Bachelor’s Degree or higher in Science or related scientific disciplines
About 5 +years of relevant technical work experience in Nutraceutical / Food/ pharmaceutical /biotech industry
OR a combination of education and experience equivalent to the above requirements.
Knowledge and compliance to GMP and GLP including 21 CFR Part 11, CFR Part 111 & 117.
Certifications, Licenses, Credentials:
N/A
Skills & Ability
Able to work in a team and assist others.
Able to perform precisely basic math calculations and follow written instructions.
Has attention to detail.
Able to follow and understand cGMP, OSHA standards etc.
Able to distinguish different shades of colors.
Intermediate user of MS Office, Excel, Word, and Outlook
Completes 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 above average written communication skills in the English language to follow the industry regulated instruction sheets.
Physical Requirements (lifting, etc.):
Able to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
Able to stand and walk on the production floor for a minimum of 6 hours per shift
Use hands to finger, handle or feel, or to operate or to control objects. Able to lift up to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
Able to occasionally work on a rolling ladder or step stool, or to lean over equipment as well as kneeling on the floor to clean under the equipment.
Able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirator.
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.
Show more
Title: Engineer II-Quality
Company: Microchip Technology
Location: Beverly, MA
