Quality Assurance Specialist

Nutramax Laboratories; South Carolina; Presencial; USD 55 000 - 75 000; Tempo integral

Resumo da oferta

Nutramax Laboratories in Lancaster, SC, is seeking a Quality Assurance Specialist to provide daily QA support in manufacturing and packaging on-site, including QA processes for CMOs. The role involves process improvements, NCR/CAPA handling, and GMP compliance to ensure product quality across operations.

The ideal candidate has a High School Diploma or GED and at least 4 years of pharmaceutical manufacturing experience, with proficiency in SAP and QA documentation.

Qualificações

• High School Diploma or GED required.
• 4 years’ experience in pharmaceutical or dietary supplement manufacturing preferred.
• Auditing experience and troubleshooting is a plus.
• Great enthusiasm and hard work ethic required.
• Detail oriented and team centered approach expected.

Responsabilidades

• Provide in-process review and training to production operators.
• Understand roles of Contract Manufacturing Organizations.
• Assist with trending and metrics in QA department.
• Familiarity with QA functions in SAP.
• Create/Revise SOPs, batch records, and other GMP documents.
• Perform non-conformance investigations and monitor NCRs/CAPAs.
• Review and release of CMO batch records and assist with in-house release.

Conhecimentos

cGMP knowledge

Attention to detail

Interpersonal skills

Critical thinking

Teamwork

Formação académica

High School Diploma or GED

Ferramentas

SAP

Qualityze

LIMBS

Excel

Word

Outlook

Descrição da oferta de emprego

The hours for this role are Monday - Friday 8:30am - 5:00pm. This position is located at 946 Quality Drive, Lancaster, SC 29720.

Description

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.
• 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.
• 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.

Supervisory Responsibilities:

None

Nutramax desires to provide a drug-free, healthful, and safe workplace. We hold a zero-tolerance policy for drug use. Employment is contingent upon successfully passing a preemployment background check and drug screen (subject to applicable law).