QA Specialist

Nutramax Laboratories, Inc.; Lancaster (SC); On-site; USD 55,000 - 85,000; Full time

Job summary

Nutramax Laboratories, Inc. is seeking a Quality Assurance Specialist to support on-site QA in Manufacturing and Packaging and related GMP functions. The role emphasizes process improvements, non-conformance investigations, and collaboration with the QA department and CMO activities.

Ideal candidates have strong cGMP knowledge, attention to detail, and the ability to work independently or in a team. Familiarity with SAP and QA-related software is a plus, with a focus on documentation and

Qualifications

• Requires cGMP knowledge in a dietary supplement or pharmaceutical environment.
• Strong interpersonal skills and the ability to interact with all staff levels.
• Attention to detail with process analytical skills; ability to learn Nutramax procedures.

Responsibilities

• Provide In-process Review and Training to production operators.
• Assist with trending and developing QA metrics through the QA department.
• Review and release of CMO batch records and assist with in-house batch release.
• Perform Non-conformance investigations and monitor NCRs/CAPAs.
• Create/Revise SOPs, batch records, and other GMP documentation.
• Support QA and Manufacturing through process improvements and cross-function collaboration.
• Communicate effectively with other departments and work within a team environment.

Skills

cGMP knowledge

Interpersonal skills

Critical thinking

Team collaboration

Attention to detail

Independent worker

Documentation review

Communication

Education

High School Diploma or GED

Tools

SAP

Qualityze

LIMBS

Excel

Word

Outlook

Job 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.

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.

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).