Quality Assurance Manager

Tower Laboratories, Ltd.; Montague Township (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

HSA option

Dental insurance

Vision insurance

Accident, critical illness, and life保险

Voluntary life insurance

Company-paid life insurance

Long-term disability

401(k) with employer contribution up

Paid time off, sick time, and 9 paid <

Job summary

Tower Laboratories, Ltd. is seeking an experienced Quality Assurance Leader to oversee QA auditing in the Montague facility and align QA activities with Tower Labs’ business objectives.

The role includes supervising auditors, conducting inspections, supporting manufacturing, and maintaining proper documentation. Responsibilities include leading audits, reviewing packaging and BOMs, investigating root causes, and ensuring cGMP compliance and timely communication with stakeholders.

Qualifications

• Five years experience in Quality Assurance leadership in the pharmaceutical industry.
• Demonstrated current knowledge of cGMP regulations and industry standards.
• Ability to train others and provide guidance.
• Strong team player, demonstrated team attitude and behaviors.
• Working knowledge of MS Word and MS Excel.
• Strong writing skills.
• Excellent organizational skills; ability to delegate.
• Strong attention to detail.
• Strong problem-solving and analytical skills.

Responsibilities

• Oversee daily activities of QA Auditor(s); provide direction and training as needed.
• Ensure compliance with FDA rules and cGMP processes.
• Conduct packaging audits to ensure final product meets specifications and AQL.
• Lead investigations and determine root causes when issues occur.
• Perform internal GMP audits and maintain compliance with procedures.
• Participate in onsite audits as needed.
• Audit finished batch production documents and release of finished product.
• Communicate deficiencies to key personnel and work with cross-functional teams to resolve issues.

Skills

QA Leadership

cGMP knowledge

Training others

Team player

MS Word

MS Excel

Writing skills

Organization

Problem-solving

Education

Bachelor’s degree in Science

Equivalent QA experience

Job description

Tower Laboratories is a leading effervescent product manufacturer in the U.S. We develop and manufacture over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets and other consumer products on a contract basis. We are continually expanding our effervescent product base and currently have several new and interesting products in the research and development phase right now. We are a family owned company and have been in business for over 40 years.

POSITION SUMMARY:

Responsible for the operational and administrative duties needed to ensure that the Quality Assurance auditing in the Montague facility operates effectively and efficiently and is fully integrated with Tower Labs’ business objectives. This includes supervising auditor(s), performing necessary inspection and testing required for product release, supporting the manufacturing operation, providing timely information and communicating with both internal and external customers. This position also has responsibilities with proper documentation.

ESSENTIAL FUNCTIONS:

• Oversee daily activities of QA Auditor(s); providing direction of responsibilities and guidance for completing tasks as well as providing any necessary training.
• Familiar with FDA rules, regulations and understanding of FDA processes.
• 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.
• Lead and conduct investigations, as directed, and collect information to assess root causes when product or processes are not meeting specifications.
• Conduct internal GMP audits to ensure compliance to cGMP and internal procedures and policies.
• Participate in, lead and/or co-lead all audits conducted onsite.
• Audit finished/completed batch production documents and release of finished product.
• Communicate identified manufacturing deficiencies to key personnel (Machine Operator, Quality Manager, Production Supervisor etc.).
• Work with cross functional team to determine and correct root cause issues.
• Coordinate packaging specifications; review and approve Bill of Materials (BOM).
• Perform all work in accordance with established Safety, cGMP and company procedures; support company mission and values.
• Other responsibilities as assigned.

ESSENTIAL SKILLS and EXPERIENCE:

• Five years experience in Quality Assurance leadership in the pharmaceutical industry.
• Demonstrated current knowledge of cGMP regulations and industry standards.
• Ability to train others and provide guidance.
• Strong team player, demonstrated team attitude and behaviors.
• Working knowledge of MS Word and MS Excel.
• Strong writing skills.
• Excellent organizational skills; ability to delegate.
• Strong attention to detail.
• Strong problem-solving and analytical skills.

EDUCATION:

Bachelor’s degree in Science preferred; equivalent experience in Quality Assurance in the pharmaceutical industry may be substituted.

BENEFITS AND SALARY INFORMATION:

Full-time employees are eligible for the following benefits after meeting any applicable waiting periods:

• Medical insurance
• HSA option
• Dental insurance
• Vision insurance
• Accident, critical illness, and hospital indemnity insurance
• Voluntary life insurance
• Company-paid life insurance
• Long-term disability coverage
• 401(k) with an employer contribution of up to 3%
• Paid time off, sick time, and 9 paid holidays

Tower Labs is an Equal Opportunity Employer. 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 applicable law.