Quality Assurance Director

LAMPIRE Biological Laboratories, Inc.; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Job summary

Lampire Biological Labs seeks a Quality Assurance Director to lead quality compliance and drive improvements across multiple facilities in a fast-paced biotech setting.

The role directs QA and Document Control, ensures ISO, FDA, EU, and USDA regulatory alignment, and oversees audits, training, and supplier management. Strong communication and leadership are essential for success.

Qualifications

• Minimum 5 years QA management experience.
• Experience with ISO 9001, ISO 13485 and/or 21CFR820.
• Experience with audits/inspections by clients and regulators.
• Knowledge of cGMP quality systems and manufacturing ops; 21CFR211/58 a plus.
• USDA shipping requirements for animal blood products preferred.
• Strong written communication and MS Office skills.

Responsibilities

• Oversee QA and Document Control staff.
• Establish and monitor Quality Policy and objectives.
• Lead audits: client, regulatory, and internal.
• Maintain company-wide training program and staff training.
• Serve as Management Representative.
• Coordinate Management Review meetings and follow-up.
• Review/approve QA docs, supplier/customer agreements.
• Lead CAPAs for complaints, NCRs, and audit findings.
• Manage supplier qualification, audits, and surveillance.
• Oversee change controls, documentation, validation, and production controls.

Skills

Quality management

ISO 9001

ISO 13485

21 CFR 820

Regulatory audits

cGMP

MS Office

MS Excel

MS Word

MS Access

Documentation control

Training & development

Education

BS in science

Tools

MS Excel

MS Word

MS Access

Job description

Are you looking to increase your impact on life sciences? Lampire Biological Labs is a premier biotech life science company dedicated to providing biological reagents to the pharmaceutical, diagnostic, and biotech industries and is seeking a motivated Quality Assurance Director to lead quality compliance and drive quality improvement. If you thrive in a fast-paced environment, take pride in running a compliant facility, and love developing talented teams, this is your opportunity to make a mark.

Why Join Us?

Lampire offers competitive compensation, comprehensive health and retirement benefits, and an environment where operational initiative is recognized and rewarded.

Scope of Responsibility:

Planning, implementation and surveillance of entire QMS; ensure compliance with ISO, FDA, EU and USDA regulations (6 facilities across state of PA).

Supervisory Responsibilities:

Supervise and manage all QA and Document Control staff.

Position Requirements:

Note: Qualifications are based upon education, resume and/or work experience.

• Minimum 5 years of experience in quality assurance management role.
• Experience with ISO 9001, ISO 13485 and/or 21CFR820.
• Experience with client and regulatory audits/inspections.
• Experience with cGMP (21CFR820) quality systems and manufacturing operations, experience with 21CFR211 and/or 21CFR58 is a plus.
• Experience with USDA Requirements for shipping animal blood products is preferred.
• Well-organized and detailed oriented professional, with strong written communication skills.
• Good computer skills with working knowledge of MS office such as Word and Excel
• MS Access knowledge would be a plus.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and meet deadlines.
• Ability to perform all work, and interact with others, in a safe and responsible manner.

Responsibilities include (but are not limited to):

• Responsible for all QA and Document Control staff.
• Establish and monitor performance of company Quality Policy and Objectives
• Preparation, hosting, execution, and responses for client, regulatory and internal audits
• Maintain and evaluate effectiveness of company-wide training program.
• Perform staff and all company training.
• Serves as Management Representative
• Preparation, Coordination, Reporting and Follow up on all Management Review meetings
• Document, review and approval of Quality Technical, Supply and Distribution Agreements
• In charge of all investigations, corrections and CAPAs for customer complaints, NCRs and audit findings
• Supplier Management program, involving ranking, auditing and surveillance of all suppliers.
• Review and Approval of all controlled documents, customer specifications, change controls and validations, including software validation.
• Production and Process Controls which include, material receiving, calibration and equipment maintenance, environmental monitoring and pest management, identification and traceability, record review, labeling, packaging and shipping activities.
• Assists QA Specialists in release of finished goods, Material Receiving and Quarantine and disposition of nonconforming materials.
• Completes client requested documentation such as supplier questionnaires and health certificates.
• In charge of all facility record retention and archival program.
• Ability to perform all work and interact with others in a safe and responsible manner.
• Other duties as assigned

Education:

• BS Degree in scientific discipline preferred
• Minimum 5 years of experience in quality assurance management role
• Physical Requirements:
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift and move up to 25 pounds at a time.
• Must be able to access and navigate each department at the organization’s facilities.

Working Conditions:

• Conditions inside the office are generally quiet, periodically there may be mid-level noise from various equipment when traveling to other facilities.
• While performing the duties of this job, the employee is frequently standing, walking, and sitting.