Quality Assurance Specialist - Document and Training Management

About Us:

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs.

Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for - Meitheal (Mee*hall): working together toward a common goal, for the greater good.

Position Summary:

The Quality Assurance Specialist position is responsible for Meitheal's Document and Training Management Programs. This will require working with our external Safety Data Sheet Vendor, monitoring the periodic review process for controlled documents, supporting day-to-day activities associated with the document lifecycle, monitoring training, performing annual training assessments and supporting the change control, batch review and new product launch activities, as needed. Previous experience with documents or training management in a CGMP environment is a plus. This is a Chicago-based hybrid role.

Why Work with Us?

• Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
• Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
• Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
• Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Responsible for Administration of Meitheal's Document Management Process
• Works in collaboration with Safety Data Sheet Vendor and contract manufacturing partners to obtain necessary documents for vendor to develop Safety Data Sheets.
• Initiates, processes and monitors Meitheal Controlled Documents within Meitheal's TrackWise Digital System including but not limited to Policies, Procedures, Work Instructions and Safety Data Sheets.
• Formats red-lined or updated Controlled Documents in collaboration with document owners, as necessary
• Monitors Controlled Document periodic review cycle updates and works in collaboration with Document Owners, external vendors, and partners, as applicable, to meet review timelines.
• Responsible for Administration of Meitheal's Training Management Process for all departments.
• Creates new and updates existing Training Plans in TrackWise Digital in collaboration with department management.
• Creates on the Job Training in TrackWise Digital in collaboration with department management, as needed.
• Creates Training Quizzes in TrackWise Digital, in collaboration with document or training owners, as needed.
• Assigns training within TrackWise Digital system to new employees and existing employees, as needed.
• Monitors Meitheal's employees training to completion ensuring training timelines are met.
• Prepares and Presents Annual CGMP presentation in collaboration with other Quality team members.
• Conducts Annual Training Assessment.
• Conducts New Employee Training for TrackWise Digital, Adobe Sign, and Master Product Portal.
• Prepares training metrics for Management Review.
• Supports management during external inspections.
• Remains current in regulatory trends and requirements.
• Other duties as assigned.
• Strong organization skills and attention to detail is a requirement.

Competencies

• Code of Federal Regulations and cGMP's
• Strong written and oral communications skills
• Planning and Organizing
• Interpersonal
• Teamwork
• Problem Solving
• Quality Management
• Judgement
• Dependability
• Ethics

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in science or equivalent degree.
• 2-5 years' experience in Quality with a pharmaceutical company or similarly regulated industry.
• Knowledge of CGMP and GDP as well as FDA trends and guidelines.
• Strong interpersonal skills required.
• Must be a team player with good problem solving and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently.
• Ability to manage indirect relationships and projects successfully.
• Strong organization skills and attention to detail required.

Travel

No travel required.

Computer skills

Microsoft Word, PowerPoint, Excel, TrackWise Digital, Adobe Sign preferred but not required

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.