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.

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 strongly preferred.

Physical Demands, Mental Requirements, and Work Environment:

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work, PC use, and evaluation of test specimens.

Mental Requirements

• Effective written and oral communication skills;
• Strong organizational, planning, and communication skills;
• Ability to apply deductive reasoning and analytical thoughts to understand complicated issues;
• Demonstrates exceptional time management skills;
• Ability to work in an independent manner, as well as a group environment;
• Ability to multi-task, set priorities, meet deadlines and effectively deal with a high level of office stress; and
• Ability to maintain confidentiality of work assignments and personnel issues.

Disclaimer:

• The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN "AT WILL" EMPLOYMENT.