Job Description

The Quality Assurance Specialist position is responsible for 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 document or training management in a CGMP environment is a plus. This is a Chicago-based hybrid role.

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

• Responsible for Administration of Document Management Process

oWorks in collaboration with Safety Data Sheet Vendor and contract manufacturing partners to obtain necessary documents for vendor to develop Safety Data Sheets.

oInitiates, processes and monitors Controlled Documents within TrackWise Ditigal System including but not limited to Policies, Procedures, Work Instructions and Safety Data Sheets.

oFormats red-lined or updated Controlled Documents in collaboration with document owners, as necessary

oMonitors 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 Training Management Process for all departments.

oCreates new and updates exsisting Training Plans in TrackWise Digital in collaboration with department management.

oCreates on the Job Training in TrackWise Digital in collaboration with department management, as needed.

oCreates Training Quizzes in TrackWise Digital, in collaboration with document or training owners, as needed.

oAssigns training within TrackWise Digital system to new employees and exsisting employees, as needed.

oMonitors employees training to completion ensuring training timelines are met.

oPrepares and Presents Annual CGMP presentation in collabration with other Quality team members.

oConducts Annual Training Assessment.

oConducts New Employee Training for TrackWise Digital, Adobe Sign, and Master Product Portal.

oPrepares 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"

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 accommodations 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

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee may have to sit for prolonged perids, stand and walk occasionally while in ofice. The employee is frequently required to talk or hear.

Work Environment The noise level in the work environment is usually moderate.

AAP/EEO Statement Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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