Validation Associate - Hauppauge, United States - LNK International, Inc.

LNK International, Inc.

Verified Company

Hauppauge, United States

6 days ago

Posted by:

Mark Lane

beBee recruiter

Description

LNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over the counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation.

What sets LNK apart? We believe it is our employees. There is a commitment to quality in every department at LNK.

As a member of our Validation department you will be working with dedicated professionals who support and interact with all areas of the company.

Our full time employees enjoy competitive benefits including:

401(k) with generous employer match
Health Insurance
Dental Insurance
Paid holidays
Paid vacation

Shift:
Day Shift

The Validation Associate reports to the Manager and is a key member of the Validation team.

Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system on the product quality.
Perform design review to ensure the equipment is installed and operates according to the User Requirement Specifications.
Perform Commissioning, Qualification and Validation of the equipment and systems.
Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to manufacturing equipment and packaging line equipment.
Characterize equipment operation processes and define critical process parameters and critical quality attributes.
Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.

Job Types:
Full-time

Schedule: 8 hour shift

Education:
Bachelor's (preferred)

Experience:
Entry level, 1-2 years (preferred)

The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be _modified_ in the future. When _determining_ a team member's base salary and/or rate, several factors may be considered as _permitted_ by law_._