Quality Systems Specialist

ALI Pharmaceutical Manufacturing (ALI-PM) is a great employee focused company to work for!

At ALI-PM, we are looking for candidates with varied backgrounds and skills. Diverse ideas come from diverse people, and we are devoted to offering an all-encompassing work environment where everyone feels valued and respected. Our pace of work enables fast learning and fosters an environment where you can stretch yourself and make an impact. We offer a variety of job specific and business skills programs and trainings to our employees. As a member of our team, you’ll have an opportunity to draw from those resources when you need them, and likewise, contribute your expertise when you have something to share.

We offer a highly competitive compensation package (salary and bonus) as well as a comprehensive, family-friendly benefits package including:

• Exceptional family medical, dental, and vision benefits (100% company paid premiums). 100% paid deductible/out of pocket expenses for Medical
• Paid time off and sick leave
• 9 paid holidays
• Exceptional 401k fund contributions (up to 9%)
• Great schedules
• Wellness incentives

Pay is based on experience.

Take your career to the next level by applying today!

Quality Systems Specialist

We have a career opportunity for a Quality Systems Specialist.  As a Quality Systems Specialist, you will be responsible for supporting ALI Pharmaceutical Manufacturing's (ALI-PM) quality operations including managing and storing of cGMP documentation and records issuance. 

This position will be located at 4410 S 102^nd St., Omaha, NE, working with different management levels and support personnel in other office locations.

The impact you will have:

• Responsible for ALI Pharmaceutical Manufacturing (ALI-PM) Quality Operational Support including managing and storing of cGMP documentation, records issuance, and provide support in QA oversight of manufacturing activities as needed.
• Manage ALI-PMs documentation program lifecycle from issuance of documents to archival. Provide oversight of inventory tracking system for archived cGMP documentation.
• System Administration of Master Control.
• Prepare and review documentation for release of finished product. Provide support in final release of finished product.
• Partner with manufacturing to provide QA oversight of operations and to solve in any quality concerns during the manufacturing of product.
• Write, review, and approve SOPs and Forms for manufacturing processes.
• Report quality issues to management.
• Educate manufacturing team on quality control issues and work with departmental managers to improve overall company product quality.
• Conduct/assist investigation process for quality event; participating in triage events, identifying root cause and corrective and preventive action.
• As the workload demand changes for the department, additional responsibilities may be required.

What we are looking for:

• Minimum high school diploma, GED or equivalent required
• Bachelor's degree in a science discipline preferred
• Minimum of 3 years of experience with US FDA and cGMP requirements
• Minimum of 3 years of experience with Quality Assurance and/or Quality Control practices
• Basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements
• Experience managing systems, including problem-solving skills
• Strong attention to detail, time management, and organizational skills
• Advanced computer skills, including Outlook, Excel, Word, PowerPoint and quality systems (MasterControl)
• Strong verbal and written communication skills, including the ability to organize information and present it to peers and members of Senior Management

ALI Pharmaceutical Manufacturing, LLC is an Equal Opportunity Employer and participates in E-Verify.