Position Title: Senior QA Manager of Document Control and Training Department: Quality Assurance
Reports To: Head of Quality Work Location: Decatur, Illinois

Position Summary:
The Senior QA Manager of Document Control and Training will be responsible for the oversight of the documentation and training programs.

This includes but is not limited to: Standard Operating Procedures (SOPs), Specifications, Document Change Requests (DCRs), Master Batch Records (MBRs), Protocols, Training Curriculum, and Quality Management Systems (QMS).
This individual will work in a detail oriented, compliant manner to ensure the facility operates in alignment with Rising policies, procedures, and cGMPs.

Essential Duties & Responsibilities:
Responsible for the overall direction, coordination, and evaluation of the Document Control and Training departments.
Lead and assist with maintaining the electronic Document Management System (DMS).
Lead and assist with maintaining the electronic Learning Management System (LMS) for training.
Maintain training curricula for positions at the site.
Responsible for organizing and archiving cGMP documents on site.
Compile and report metrics for Quality Assurance Documentation and Training.
Evaluates quality processes for alignment with cGMPs and evolving regulatory expectations.
Assist with investigations and review/approve as needed.
Review all controlled documents through Document Change Request (DCR) process.
Implements and enforces systems, policies, and procedures.
Assist HR with the creation and delivery of New Hire Orientation (NHO).
Assist with audits, both internal and external.

Additional Responsibilities:
Responsible for performance reviews, goal setting, and personnel development plans for Supervisor, QA Documentation Systems and QA Technicians - Documentation Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
Assists in recruiting, interviewing, and hiring qualified employees to fill open positions.
Addressing complaints and resolving personnel problems within the department(s).
Maintaining confidentiality of information.

Education and Experience:
Bachelor's Degree from a four-year accredited college or university with Major in a science related field.
Minimum of five years of cGMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry. Working knowledge, writing, and following of SOPs; document management and control system processes.

Must-Haves
USA Citizen/Green Card Holder
Must be from Pharmaceuticals Background
Should have experience with Sterile injectables
Bachelors degree in science field (Chemistry preferred) required, a minimum of 2 years experience.

Job Type: Full-time

Pay: $100,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Sterile processing: 1 year (Required)
• Pharmacy technician: 1 year (Required)
• QA: 8 years (Required)

License/Certification:

• cGMP (Required)

Ability to Commute:

• Decatur, IL 62521 (Required)

Ability to Relocate:

• Decatur, IL 62521: Relocate before starting work (Required)

Work Location: In person