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Job Description
Simtra BioPharma Solutions is seeking a Quality Client Representative to manage the CAPA Quality System and facilitate communication between Simtra and clients regarding quality-related events. The Quality Representative will interact directly with clients, providing customer service with a focus on quality and compliance. This position reports to the Manager I, CAPA/Complaints.
Responsibilities include:
- Serving as a Quality Representative for the CAPA System.
- Supporting the day-to-day operation of CAPA related recurring meetings and the CAPA Quality System.
- Training personnel on procedures and processes related to CAPA.
- Reviewing and approving local CAPAs for closure.
- Making and delivering quality decisions pertaining to the CAPA System and quality requests.
- Utilizing problem-solving tools to drive root cause analysis and appropriate corrective / preventative action.
- Escalating quality issues to impacted departmental Quality Manager and/or Quality Director as necessary for corrective action implementation.
- Authors and reviews CAPA investigations as needed to meet client delivery dates and expectations.
- Supporting CAPA System requests for external/client/internal audit activities.
- Tracking, trend, compile and report CAPA quality metrics as necessary.
- Supporting complaint investigations and review/approve level 1 complaint investigations as needed.
- Representing Quality in required client meetings.
- Understanding Quality Systems, Regulatory, and Procedural requirements that govern the client/company relationship and product.
- Partners with Program Management, Technical Services, Quality Control, and Manufacturing to provide support, align facility representation, and provide consistent quality inform.
- Negotiate and provide guidance in the approval process of Quality Agreements.
- Lead continuous improvement activities to maximize business results.
Requirements include:
- Bachelor’s degree required, preferably in a science related field and a minimum 5 years of pharmaceutical industry experience OR a Master’s degree and 3 years of pharmaceutical industry experience
- Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
- Knowledge of worldwide regulatory requirements.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Simtra BioPharma Solutions offers:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Voluntary Insurance Benefits
- Vision Coverage
- Accident Critical Illness Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
