Senior Quality Assurance Manager
4 weeks ago
Job Title: Senior QA Manager (Pharma)
Location: Decatur, IL
Type: Full-Time + Relocation + Int. travel allowance + Full benefits + Bonus
Shift Timing: 1st shift (Monday to Friday)
*Sterile Injectable experience required*
Job description:
- 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.
Job Prerequisites:
- All full-time employees are required to work a 40-hour week.
- At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines.
- All applicants must be able to meet the attendance standards.
- Working knowledge of Microsoft Office Word, Excel, Outlook, and Power Point.
- Excellent conceptualizing, analytical, and problem-solving skills.
- Experience with an Electronic Document Management System.
- Pharmaceutical industry knowledge Required.
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