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Nutrabolt · 2 days ago

Quality Assurance Specialist

Austin, TX

Full-time

Onsite

Entry, Mid Level

2+ years exp

Nutrabolt is a fast-growing, global active health and wellness company with a focus on performance-oriented brands. The Quality Assurance Specialist will be responsible for overseeing quality document operations, ensuring compliance with regulations, and conducting training on quality assurance concepts and tools.

Dietary SupplementsFitnessHealth CareMarketingNutrition

Responsibilities

Oversee all QA controlled documentation and product release related functions

Ability to write and review standard operating procedures (SOPs)

Review Production Batch Records (PBRs), COAs/COCs, QA inspection documentation, requests for reprocessing/rework, planned deviations, and requests for process deviations

Work closely with Supply Chain/Purchasing to facilitate creation/completion of deviation records to support production and/or release of finished product in accordance with Supply Chain schedules

Understand requirements needed to support release of product launches, first production runs, and/or international production for active nutrition and beverages

Support and maintain NSF Certification Program

Ability to review and interpret analytical and microbiological lab reports, including prepare samples for submission to lab for analysis and required submission forms, track and follow up on lab results based on standard turnaround times

Review and investigate product complaints

Coordinate procurement and shipment of product samples to support Quality programs as needed

Perform statistical analysis of finished product results and stability data

Work with Quality Management, Sr. Quality Technical Analyst, and/or Supplier Quality to conduct formal procedural inquiries and investigations for non-conformances and /or OOSs to identify the root cause(s), implement CAPAs, and determine disposition of finished product

Ability to provide background audit support to include documentation management, review, and submission, and coordination of subject matter experts

Oversee all QA controlled documentation and product release related functions

Ability to write and review standard operating procedures (SOPs)

Review Production Batch Records (PBRs), COAs/COCs, QA inspection documentation, requests for reprocessing/rework, planned deviations, and requests for process deviations

Work closely with Supply Chain/Purchasing to facilitate creation/completion of deviation records to support production and/or release of finished product in accordance with Supply Chain schedules

Understand requirements needed to support release of product launches, first production runs, and/or international production for active nutrition and beverages

Support and maintain NSF Certification Program

Review and investigate product complaints

Coordinate procurement and shipment of product samples to support Quality programs as needed

Perform statistical analysis of finished product results and stability data

Ability to provide background audit support to include documentation management, review, and submission, and coordination of subject matter experts

Support administrative activities as related to the QMS (Veeva) which included, but is not limited to the removal/addition of users, updating user permissions, and managing Pick Lists

Manage complex tasks individually or as part of a team to meet departmental and/or company goals

Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards, guidelines, rules, and regulations

Act as subject matter expert in the interpretation and implementation of all applicable regulatory requirements (e.g., 21 CFR Parts 117, 110, 111, Halal, Kosher, Non-GMO, etc.)

Perform other job functions as required

Qualification

CGMP complianceQuality Management SystemsStatistical analysisSOP writingReviewAnalytical lab reportsMicrobiological lab reportsASQ certificationAttention to detailOrganizational skillsCommunication skillsIndependent work

Required

A minimum of 2 years industry QA/QC experience in cGMP environment

Experience in a manufacturing environment is required

Understanding of statistics required

A robust knowledge of good documentation practices (GDP)

Strong familiarity with Microsoft suites

Excellent written and verbal communication skills

Superior attention to detail and organizational skills

Ability to work effectively with people and communicate information to obtain positive results

Comfortable working independently and able to manage time efficiently and adjust to shifting priorities

Ability to work well under tight deadlines

Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards, guidelines, rules, and regulations

Act as subject matter expert in the interpretation and implementation of all applicable regulatory requirements (e.g., 21 CFR Parts 117, 110, 111, Halal, Kosher, Non-GMO, etc.)