Quality Assurance Director at Lampire… · Pipersvil…

Quality Assurance Director

Location: Pipersville, Pennsylvania

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.