Lead, Quality

COLE-PARMER INSTRUMENT COMPANY•Raleigh, NC

13d•$70,000 - $85,000•Onsite

About The Position

The Quality Assurance Lead is an intermediate position within the NSI Lab Solutions division of Antylia Scientific. The Quality Assurance (QA) Lead will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organizations products and/or development processes. This role ensures NSI is operational on a daily basis to meet company objectives as well as ensure cGMP and ISO 17025, ISO 17034, ISO 17043 and ISO 9001 compliance. Acts as subject matter expert for Proficiency Test Program. Assists the Quality Team with the Proficiency Test data review and report generation.

Requirements

Bachelor’s Degree in life sciences related field required
3-5 years’ experience in Quality in GMP environment
Excellent technical writing, communication, and organizational skills.
Attention to detail.
Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
Strong work ethic and an ability to excel within a rapidly changing and growing organization
Proven experience as a quality assurance manager or relevant role
Thorough knowledge of methodologies of quality assurance and standards
Excellent numerical skills and understanding of data analysis/statistical methods
Working knowledge of ISO regulations (ISO 9001, ISO 17025, ISO 17043 & ISO 17034)

Responsibilities

Initiate, review, and revise company SOPs, QC records, and other compliance documentation as needed.
Participate in design control and risk management activities as needed.
Perform equipment validation as needed.
Compose audit responses to Internal Quality Audits with corrective actions and perform actions necessary for compliance and audit closure.
Review and approve quality control assay data and file as necessary, report non-conformances, forward completed quality records to QA, and maintain data trending databases and records.
Maintain and systematically review relevant department SOPs and coordinate with QA/QC Department on revisions when required.
Performs other duties as assigned.
Review Quality systems for compliance with ISO regulations
Review and update Quality Assurance Manual as needed
Review current standards and policies – suggest improvements
Standardize product development protocol
document product scope
create project/task checklist
track project status
document lessons learned
Final review/approval of SOPs as it pertains to creation or revision by staff
Create internal audit checklists and perform yearly internal audit
Create refrigerator logs and standardize across departments
Review and organize all calibration records (hoods, balances, pipettes and weights)
Suggest quality improvements to management staff
Assure the reliability and consistency of production by checking processes and final output
Review/update customer feedback forms to include metrics
Investigate customer complaints and non-conformance issues
Assure ongoing compliance with quality and industry regulatory requirements