2nd shift Quality/Compliance Auditor: 4-10''s

Job Description

Job Description

If you have an eye for detail, a passion for compliance, and a commitment to quality excellence, we'd like to meet you.   Join a team where your expertise in GMP compliance, auditing, and quality systems directly contributes to product safety and regulatory success.

We are looking for someone to join our 2nd shift team! The hours are Monday-Thursday, 3:00 PM-1:00 AM.

POSITION SUMMARY:

Responsible for the enforcement of Tower Laboratories, Ltd. quality system. Conduct audits related to all aspects involved in the production of drugs, medical devices, and non-drug products manufactured at Tower Laboratories to ensure cGMP compliance and production of quality product.

ESSENTIAL FUNCTIONS:

• Perform product manufacturing audits throughout process through observation and by conducting in-process testing to ensure product meets specifications.
• Conduct packaging audit ensuring final product meets packaging specifications and is within the allowed accepted quality limits (AQL); inspect all incoming packaging components, ensuring specifications are met by performing appropriate tests following determined component specifications.
• Conduct investigations as directed and collect information to assess root causes when product or processes are not meeting specifications.
• Assist in the conduct of internal audits of cGMP to ensure compliance to cGMP and internal procedures and policies.
• Audit finished/completed batch production documents for procedural or mathematical errors prior to final review and release of product by the QA Manager.
• Communicate identified manufacturing deficiencies to key personnel (Machine Operator, QA Manager, Technical Director, Production Manager, & VP of Operations).
• Verify that all instrumentation used are calibrated and perform equipment calibrations as identified.
• Work as a team member; be cooperative with all departments and staff to meet company objectives.
• Perform all work in accordance with established Safety, cGMP and company procedures.
• Other responsibilities as assigned.

ESSENTIAL SKILLS AND EXPERIENCE:

• Minimum of 2 years of pharmaceutical experience, in the Quality Assurance or Regulatory field.
• Demonstrated current knowledge of cGMP regulations and industry standards.
• Working knowledge of MS Word and MS Excel.
• Ability to read and follow directions, complete paperwork and communicate effectively in English.
• Strong writing skills.
• Excellent organizational skills; strong attention to detail.
• Good interpersonal skills; ability to communicate effectively with all levels of plant personnel.
• Strong team player, demonstrated team attitude and behaviors.

EDUCATION:

High school diploma or equivalent.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law .