QA Specialist

Description

The hours for this role are Monday - Friday 8am - 4:30pm.

Summary of the Position: The Quality Assurance Specialist is responsible for the daily Quality Assurance support in the Manufacturing and Packaging processes on-site as well as all Quality Assurance processes related to CMO. In this role, the QA Specialist will support the Quality Department and Manufacturing through process improvements, non-conformance investigation and other GMP functions; this position requires the QA Specialist to be flexible to support QA and business operations as needed.

Roles and Responsibilities:

· Provide In-process Review and Training to production operators.

· Understand the roles and responsibilities of the Contract Manufacturing Organizations.

· Assisting with trending and developing metrics through QA department.

· Assisting Qualityze functions.

· Familiarity with QA Functions in SAP.

· Creating / Revising process changes, SOPs, batch records, and other GMP functions.

· Perform Non-conformance investigations.

· Monitor the status of NCRs and CAPAs for completion and reoccurrences.

· Review and release of CMO batch records and assist with in house batch release.

· Will assist in the correction of deficiencies found within the documentation review per cGMP, Nutramax SOPs, Contract Manufacturing Organization (SOPs), and Global Regulations criterion.

· Must be able to effectively communicate with other departments and function within a team environment.

· Perform other assigned duties as may be required in meeting company objectives.

· Regular attendance is required.

Minimum Requirements:

· Must have working knowledge of cGMP (dietary supplement or pharmaceutical environment)

· Good interpersonal skills and the ability to interact with all staff levels.

· Critical thinking skills to learn Nutramax procedures and predict whether proposed changes will be effective.

· Must be able to work independently and within team environment, according to specific, written and verbal instructions, presented by supervisor or designee.

· Previous knowledge and understanding of production processes in a cGMP or pharmaceutical environment desired.

· Attention to detail and some process analytical skills necessary.

· Regularly required to stand and bend

· Must be able to use hands and arms to lift and reach

· Ability to climb up and down stairs

· Ability to lift, pull and push a minimum of 50 pounds

· Ability to use both arms to push, pull or lift.

· Ability to bend and squat

· Requires the ability to use fractions, decimals, and commercial arithmetic as well as a basic knowledge of grammar, spelling and punctuation.

Education and Experience: This position requires a High School Diploma or GED. 4 years’ experience in the pharmaceutical or dietary supplement manufacturing environment preferred. Auditing experience and troubleshooting is a plus.

Great enthusiasm and hard work ethic is a must. Detail oriented and team centered approach is required. Software skills preferred- Excel, Word, Outlook, SAP, Qualityze, LIMBS, etc.