QA Specialist at Nutramax Laboratories

, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

0.0

Posted On

22 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP, Non-conformance Investigation, SAP, Qualityze, SOP Creation, Batch Record Review, CAPA Monitoring, Process Improvement, Auditing, Troubleshooting, Analytical Skills, Interpersonal Communication

Industry

Manufacturing

Description

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.

Responsibilities

The QA Specialist provides daily quality assurance support for on-site manufacturing, packaging, and CMO processes. Key duties include performing non-conformance investigations, reviewing batch records, and maintaining GMP documentation.