Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Company Overview: Lampire Biological Laboratories is a biotech life science company specializing in the production of antibodies, proteins, and other biological products. We offer innovative solutions to meet the research and development needs of our clients in the pharmaceutical and diagnostic industries. We are committed to delivering high-quality products and services to our customers while fostering a culture of teamwork and innovation.

Job Description: The Quality Assurance Specialist is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Supports change control process, CAPA system, deviation process, nonconforming material process, customer complaints, supplier approval, material receiving, internal audit process and document control. Requires experience in ISO-9001/ISO 13485 or cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts.

Responsibilities:

• Must be able to take a leadership role in Quality related decisions.
• Proactively ensure batch records are reviewed prior to material release, ensuring paperwork is completed accurately, neatly and fully.
• Performs through root cause analysis and establishes in-depth and robust corrective and preventative actions for both internal non-conformances and customer complaints.
• Assesses materials received against internal procedures and performs the necessary approval to release materials.
• Ability to read unplanned deviations, change controls, validations and other technical documents/reports to identify errors and/or potential non-compliance issues and to assess potential product/process risk.
• Complete supplier approval paperwork for new incoming suppliers.
• Participate in internal audits and inspections including planning for audits, execution, and follow-up on audit findings.
• Assists in the tracking and maintenance of document control activities.
• Write, revise and review standard operating procedures (SOPs) and custom specifications.
• Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base.
• Other duties as assigned.

Qualifications:

• 4-year college degree in quality/compliance related field or science-related field with 2-4 years related experience.
• Possess a great attention to detail.
• Must be able to work independently with minimal direction or oversight.
• Must be able to maintain accurate and organized records.
• Windows-based computer skills, familiarity with Microsoft Word and Excel.
• Good organizational skills with ability to manage multiple priorities.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 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.

We offer a competitive salary and benefits package, including health insurance, 401k, paid time off, and opportunities for professional development. If you are a motivated and detail-oriented individual looking to join a dynamic team, we encourage you to apply for this exciting opportunity.

Lampire Biological Labs, Inc. is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, or national origin.