Job Description
Job Overview:
Job Title: Lead, Quality
Reports To: Manager, Operations
Position Location: Raleigh, NC
FLSA Status (Exempt/Non-Exempt): Exempt
Position Summary:
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.
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 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
Education:
- Bachelor’s Degree in life sciences related field required
Experience:
- 3-5 years’ experience in Quality in GMP 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
- 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)
Compensation & Benefits:
- Salary Range: $70k-$85k, 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.
