Quality NA Compliance Auditor

Description: - Quality NA Compliance Auditor (DSM01102)

Quality NA Compliance Auditor-DSM01102

Description

The NA Compliance Auditor performs local and regional auditing functions to ensure Quality System requirements (ISO, GMP, Regulatory etc.) are maintained throughout the regional value chain. They report to the Director NA Quality on all auditing activities.

They educate, train and coach NA DNP personnel on the criticality of GMP and Quality Management System activities and give recommendations and guidance to regional management on best practices.

They plan, schedule and conduct first and second party cGMP (i.e. Food, Dietary Supplement, API) and ISO QMS and EMS audits as required to ensure compliance to statutory requirements (i.e. CFR) and QMS and EMS standards

The NA Compliance Auditor will support and coordinate efforts within the DNP business unit to maximize the efficiency and effectiveness of the regional QMS and EMS process

These efforts will include the auditing of policies, procedure, validation activities to support GMP activities at toll manufactures and contract labs. These activities will require the understanding of site, regional and global IT systems, organizational structures, local and regional work processes.

The NA Compliance Auditor will have competencies in current production technology and be capable of making recommendations for technological improvements. They will provide recommendations for "best practices" and ensure follow-thru and verifications are complete as appropriate.

The NA Compliance Auditor will need to communicate with the global Quality, Manufacturing and Product Management organization to ensure alignment of processes and system. These communication activities will require diplomacy and a "can do" attitude that promotes critical, transparent and creative solutions.

The NA Compliance Auditor will have a thorough understanding of ISO, Feed, Food, Dietary Supplement, Pharmaceutical and Cosmetic quality standards and regulations and the interfaces with the regional work processes and an awareness of global quality standards and regulations.

QA Compliance Auditor will participate, support and/or conduct:

1.      Conduct Auditing:

a.      First Party - (Internal)

b.      Second Party - (Supplier)

2.      Accountable for Third Party audits at NA toll manufacturer and contract labs- (Regulatory or Standards, i.e. verify compliance or certification)

3.      Customer Complaint Investigations with NA toll manufacturer and contract labs

4.      Deviation/Investigation Reports and Root Cause Analysis NA toll manufacturer and contract labs

5.      Conduct Internal Training Courses (i.e. auditor,)

6.      Ensure compliant Product Release at NA toll manufacturer and contract labs

7.      Knowledge of the following standards:

a.      ISO 9001 and 14001

b.      Animal Feed

c.      Food GMPs

d.      Dietary Supplement  GMPs

e.      Active Pharmaceutical Ingredients

f.        Cosmetic

g.      Kosher and Halal activities at  toll manufacturers

h.      Product Stability Testing Programs for toll manufactured products

i.        Product Quality Review (Annual Product Review) for toll manufactured products

8.      Management of Change Approvals/Implementation Locally, Regionally and Globally for toll manufacturers

9.      Preparation of Customer Letters of Acceptance, QT Letters and Signature Release Letters as it relates to NA toll manufacturer

10.  Non-Routine Laboratory Testing Requests for toll manufacturers

11.  Final Product Label Review for toll manufacturers

12.  Reprocessing Approval for toll manufacturers

13.  Monthly Material Disposition Update and KPI Tracking

14.  Hazard Analysis and Critical Control Point Evaluation

15.  Support Product Shelf-Life Extension for toll manufacturers

16.  Project Management Activities

17.  Contract lab and Toll Manufacturer Quality Agreement Preparation

18.  Departmental KPI Tracking for toll manufacturers

19.  Standard Operating Procedure (SOP) review for toll manufacturers

Capable of working in an international multi-cultural network on a local, regional and global basis. Responsible for quality related activities for multiple manufacturing sites and laboratories, unit operations, product lines and technologies.

Understand and apply numerous and varied product quality requirements for feed ingredients, food additives, dietary supplements, pharmaceutical excipients, active pharmaceutical ingredients and cosmetic ingredients.

Adaptable to rapid change and moving targets in terms of continuously evolving product quality standards, product lines and organizational changes.

Prepare contracts and Quality Agreements with contract lab and manufactures.

Interaction with representatives from international Kosher and Halal organizations. Demonstrating quality management competence and responsiveness towards customers helps to position DNP as quality leader in its chosen markets.

Qualifications

* Four year technical degree (Bachelors degree) in a related technical discipline. 3-5 years experience in Food and/or Pharmaceutical manufacturing QA is required * Broad knowledge of quality management * Lead auditor certification by a Nationally recognized organization * General knowledge of chemistry, biology and/or engineering. * Strong understanding of general management practices and processes. * Knowledge in Kosher/Halal * Knowledge in Good Manufacturing Practices for: Feed, Food, Pharmaceutical Excipient, Dietary Supplement, Active Pharmaceutical Ingredients and Cosmetic Ingredients * Strong interpersonal skills *  Operational and Quality Assurance experience in a technical position in the life science manufacturing industry (working in a QA- or QC- environment).

Experience:

As an auditor in a GMP manufacturing environment with certification (i.e. ASQ CQA) and has successfully passed a Lead Auditor Course Exam

Project management

Problem solving and decision making on quality and technical issues.

Job : Quality,Environment,Safety,Health

Primary Location : US-NJ-Belvidere

Organization : Nutrition

Schedule : Full-time

Send this job to a friend Send this job description to a friend by email. All the relevant details will be included in the message.Send this job to a friend

Please refer to job code 123160 when responding to this ad.

Category:	Accounting/Banking/Finance/Insurance
	> Auditing      > Other Banking
Location:	Belvidere, NJ
County:	Warren County
ZIP Code:	07823
Pay Rate:	Open
Job Terms:	full time
Company:	DSM
Phone:	email only please
Fax:	email only please