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Job Title: Lead, Quality

Reports To: VP, Quality

Position Location: North Charleston, SC

FLSA Status (Exempt/Non-Exempt): Exempt

Position Summary:

The Quality Lead is an intermediate position within the NSI Lab Solutions division of Antylia Scientific. 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.

Key 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 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 revisions when required.

+ Maintain QA program in state of inspection readiness.

+ 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

+ 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

Education:

+ Bachelor’s Degree in life sciences related field required

Experience:

+ 3-5 years’ experience in a Quality related field, preferably in a chemical manufacturing environment.

Minimum Requirements/Qualifications:

+ 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

+ 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 17034)

Compensation & Benefits:

+ Salary Range: $65k-$75k, depending on location, experience, and qualifications.

+ Annual-Incentive Plan (AIP): Manager-level 10%, Sr. Manager-level 15%, Director-level 20%

+ Benefits coverage begins day 1, including the following:

+ Medical, Dental, Vision Insurance

+ Disability Insurance

+ Life Insurance

+ 401(k) company match

+ Paid Time Off (15 days annually)

+ Paid Holiday time (10 company-designated days)

+ Tuition Assistance

+ Additional benefits available with company package

This position has not been approved for Relocation Assistance.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.