Quality Lead - Budd Lake, United States - Eutech Scientific Services LLC

Description

About ARL-EuTech**:

ARL-EuTech, a contract research corporation, specializes in developing innovative analytical methods with over 25 years of experience in serving the pharmaceutical and medical device industries.

Our commitment is to provide high-quality services at a competitive price.


About The Position:

The Quality Lead ensures that ARL-EuTech' s compliance to regulatory standards governing the business are met at all times and that ARL-EuTech's internal quality system is maintained at a high level under the direction of the Quality Manager (QM).

The Quality Lead works directly with the QM to maintain ARL EuTech' s training program, internal audit schedule, Proficiency Testing program, and CAPA system.

The Quality Lead facilitates quality improvements for the location of stewardship as directed by the QM.

The Quality Lead ensures that Pharma/medical device testing is in accordance with the FDA CFR Title 21 regulations as well as ISO/IEC 17025:2017 guidelines.

Responsibilities:

• Lead multiple projects with a focus on quality.
• Assist the QM with vendor audits, internal audits, and customer audits.
• Participate in governmental and ISO accreditation audits.
• Author new and revised Standard Operating Procedures.
• Perform document review including, but not limited to, laboratory notebooks, calibration records, and raw data.
• Prepare reports and responses to assigned vendor, internal, and customer audits.
• Oversee the development of corrective action plans in conjunction with the QM and Laboratory Management.
• Assist the QM with overseeing ARL-EuTech' s training program for location of stewardship. Assist the QM with overseeing ARL EuTech' s
• Proficiency Testing program.
• Assist the QM with overseeing customer complaints and ensuring that quality needs of the Clients are met.
• Work with the QM and Laboratory Management to ensure corrective actions and complaints are addressed promptly.
• Work closely with Lab Management to champion quality and process improvement in the lab.
• Adhere to all GLP, cGMP, and ISO regulations as they pertain to the position's function and duties.
• Participate in professional development courses and conferences as it pertains to the duties of this position and as directed by the Director of Quality.
• Document and address quality concerns and complaints, initiating CAPA as necessary.
• Create Laboratory Quality Reports for the QM as needed.
• Schedule, participate in, and/or lead Quality Management Meetings.
• Other duties as assigned by the QM

Requirements and Expectations:

• Bachelor's degree in Chemistry, Microbiology, Quality Management, or a closely related field.
• 1+ years experience in quality leadership with at least 1 year of analytical lab experience.
• Knowledge of scientific method, data interpretation, and analyses.
• Strong interpersonal skills both written and verbal.
• Must be familiar with ISO/IEC 17025:2017, FDA cGMP (CFR Part 21) and GLP regulations.
• Ability to lead small teams (25+ members) on various projects within a lab setting.
• Experience performing internal audits and overseeing corrective actions.
• Ability to lift at least 30 lbs.
• Willing to spend at least 15% of time traveling.
• Comfortable working in a BSL II lab.
• Able to converse fluently in English, verbally and in writing.
• Able to complete work on time and meet changing scheduling demands.
• Strong attention to detail.
• Able to handle fastpaced, highpressured work demands with confidence and professionalism.
• Abide by ARL-EuTech's drug testing, background check, and drugfree policies.
• Good understanding of laboratory information systems and laboratory equipment.

Preferred:

• Master's degree in Chemistry, Microbiology, Quality Management, or a closely related field.
• ASQcertified Internal Auditor
• ASQ CPGP Certification
• ASQ CMQ-OE Certification
• Experience working in a nonclinical pharmaceutical laboratory.
• Experience with cGMP level method validations and laboratory cleaning validations.
• Experience with ISO 10993, ISO 17043, USP 1663, and/or USP 1664.

COMPENSATION COMMENSURATES WITH EXPERIENCE AND EDUCATION

REPORTS TO:

• ARL Lab Operations Management
• Director

ARL-EuTech offers a salary and benefits package competitively placed within the local market. We promote a culture where motivated, customer-oriented employees can flourish, increase and focus on personal and professional growth.

We offer medical insurance plans, 401K Retirement Plan paid time off (vacation, sick, holiday), in a very relaxed family environment.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.


ABOUT ARL-EuTech
Analytical Resource Laboratories LLC is a third-party quality testing laboratory in the food, cosmetics, dietary supplements, and pharmaceutical industry. It was established on January 1, 2000. In 2015