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.