Full-Time

Quality Auditor

Life Sciences

Posted on 4/18/2024

SQA Services

201-500 employees

Global supplier quality services and data

Data & Analytics

Industrial & Manufacturing

Mid

New York, NY, USA

Requirements

Familiarity with pharmaceutical or related manufacturing processes
Thorough knowledge of GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc.)
Strong QMS/GMP Auditing experience
Experience in conducting Supplier or External audits
Knowledge of FDA Regulations, Eudralex, Canada GMP, ICH Q7, IPEC Excipient GMPs, IPEC GDP, ISO standards, WHO Guidelines, and other international GMP guidelines
Strong English communication skills

Responsibilities

Performing Quality System and GMP compliance Audits of Suppliers in Pharmaceutical or Cosmetics manufacturing industries
Mitigating risk across customers' supply chains through Supplier Audit programs
Working directly with SQA Services headquarters personnel in Los Angeles, USA
Traveling to various supplier locations for audits

SQA Services is a leading Quality Assurance and Supply Chain consultancy firm. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients leverage SQA’s network of Quality Professionals in more than 50 countries as an extension of their own Supplier Quality teams.

Job Title: Quality Auditor / GMP Auditor

Description and Requirements:

Auditor will be responsible for performing Quality System and GMP compliance Audits of Suppliers to the Pharmaceutical or Cosmetics manufacturing industries. The overall goal of SQA’s Supplier Audit programs is to mitigate risk across our customers’ supply chains. Supplier Audits typically last 1-3 days on-site not including audit report generation.

The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc…). The auditor must have strong QMS/GMP Auditing experience having conducted many Supplier or External audits throughout his or her career.

Relevant quality standards and audit types include, but are not limited to

·FDA Regulations:

o21 CFR part 210/211 (current Good Manufacturing Practice for Pharmaceuticals)

o21 CFR part 820 (Medical Devices)

o21 CFR part 11 (Electronic Records)

o21 CFR part 58 (Good Laboratory Practices)

·Eudralex vol. 4

·Canada GMP

·ICH Q7 – Active Pharmaceutical Ingredients / APIs

·IPEC Excipient GMPs

·IPEC GDP

·ISO 13485

·ISO 17025

·ISO 9001

·WHO Guidelines

·Other international GMP guidelines

The Quality Auditor must have strong English communication skills, both written and verbal. Auditor will work directly with SQA Services headquarters personnel in Los Angeles, USA, but can be located anywhere in the world.

This job is done on a contract basis where you are paid per audit. This position requires travel to various supplier locations. All travel and expenses are covered by SQA Services with approval.

SQA Services

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At SQA Services, Inc., employees are at the forefront of the supplier quality services industry, engaging with the patented STEPQ technology to provide crucial, real-time quality data for quality-critical industries. This role offers a unique opportunity to work within a vast network of experienced professionals in over 50 countries, fostering a rich environment of learning and innovation. The company is committed to maintaining high standards of quality assurance and streamlining global operations, making it an ideal workplace for those passionate about impacting various industries positively through superior quality management systems.

Company Stage

M&A

Total Funding

$282M

Headquarters

Palos Verdes Estates, California

Founded

1995

Growth & Insights

Headcount

6 month growth

↑ 3%

1 year growth

↑ 5%

2 year growth

↑ 11%