Simtra BioPharma Solutions
Quality Client Representative
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Overview
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization with facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany. We offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, all directly injected into patients worldwide. There is a strong emphasis on quality and regulatory standards and support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams aim to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We pursue a growth mindset, develop new skillsets and strive to exceed expectations and customer needs. Make it TOGETHER – We work as one, respecting every voice and leveraging diverse strengths across teams. Make it RIGHT – We uphold a high standard of excellence, fulfilling commitments to customers, patients and colleagues. Make it COUNT – We take pride in our work and its impact on patient health. Role
The Quality Representative is responsible for activities associated with the CAPA Quality System and collaborates with Project Management to facilitate communication between Simtra and clients regarding critical quality-related events. The role interacts directly with clients and provides exemplary customer service while focusing on quality and compliance. This position reports to the Manager I, CAPA/Complaints. Responsibilities
Serve as a Quality Representative for the CAPA System, ensuring compliance with corporate and regulatory guidelines for internal and external customers. Support day-to-day operation of CAPA-related recurring meetings and the CAPA Quality System. Train personnel on CAPA procedures and processes. Review and approve local CAPAs for closure, ensuring appropriate work is performed and documented. Make timely quality decisions related to the CAPA System and quality requests. Apply problem-solving tools to drive root cause analysis and appropriate corrective/preventive actions. Escalate quality issues to the appropriate Quality Manager or Quality Director for corrective action. Author and review CAPA investigations as needed to meet client delivery dates and expectations. Support CAPA System requests for audits (external, client, internal). Track, trend, and report CAPA quality metrics as necessary. Support complaint investigations and review/approve level 1 investigations as needed. Represent Quality in required client meetings and maintain knowledge of Quality Systems, Regulatory and Procedural requirements governing client relationships and products. Collaborate with Program Management, Technical Services, Quality Control and Manufacturing to provide support and align facility representation for consistent quality information. Negotiate and provide guidance in the approval process of Quality Agreements. Lead continuous improvement activities to maximize business results. Contribute to a culture of compliance and quality throughout the organization. Qualifications
Bachelor’s degree in a science-related field with a minimum of 5 years pharmaceutical industry experience, or Master’s degree with 3 years of pharmaceutical industry experience. Familiarity with quality operating procedures and regulatory requirements related to pharmaceutical, biological and biochemical quality. Knowledge of worldwide regulatory requirements. Proficiency in Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise). Physical / Safety
Duties may require overtime, including nights and weekends. Position may require prolonged sitting or standing. In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance (Spouse, Child) 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 and more) Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal and more) Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union) Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities to perform the job. It may not include all duties and responsibilities. Simtra reserves the right to modify based on business needs. Simtra is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic.
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Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization with facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany. We offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, all directly injected into patients worldwide. There is a strong emphasis on quality and regulatory standards and support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams aim to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We pursue a growth mindset, develop new skillsets and strive to exceed expectations and customer needs. Make it TOGETHER – We work as one, respecting every voice and leveraging diverse strengths across teams. Make it RIGHT – We uphold a high standard of excellence, fulfilling commitments to customers, patients and colleagues. Make it COUNT – We take pride in our work and its impact on patient health. Role
The Quality Representative is responsible for activities associated with the CAPA Quality System and collaborates with Project Management to facilitate communication between Simtra and clients regarding critical quality-related events. The role interacts directly with clients and provides exemplary customer service while focusing on quality and compliance. This position reports to the Manager I, CAPA/Complaints. Responsibilities
Serve as a Quality Representative for the CAPA System, ensuring compliance with corporate and regulatory guidelines for internal and external customers. Support day-to-day operation of CAPA-related recurring meetings and the CAPA Quality System. Train personnel on CAPA procedures and processes. Review and approve local CAPAs for closure, ensuring appropriate work is performed and documented. Make timely quality decisions related to the CAPA System and quality requests. Apply problem-solving tools to drive root cause analysis and appropriate corrective/preventive actions. Escalate quality issues to the appropriate Quality Manager or Quality Director for corrective action. Author and review CAPA investigations as needed to meet client delivery dates and expectations. Support CAPA System requests for audits (external, client, internal). Track, trend, and report CAPA quality metrics as necessary. Support complaint investigations and review/approve level 1 investigations as needed. Represent Quality in required client meetings and maintain knowledge of Quality Systems, Regulatory and Procedural requirements governing client relationships and products. Collaborate with Program Management, Technical Services, Quality Control and Manufacturing to provide support and align facility representation for consistent quality information. Negotiate and provide guidance in the approval process of Quality Agreements. Lead continuous improvement activities to maximize business results. Contribute to a culture of compliance and quality throughout the organization. Qualifications
Bachelor’s degree in a science-related field with a minimum of 5 years pharmaceutical industry experience, or Master’s degree with 3 years of pharmaceutical industry experience. Familiarity with quality operating procedures and regulatory requirements related to pharmaceutical, biological and biochemical quality. Knowledge of worldwide regulatory requirements. Proficiency in Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise). Physical / Safety
Duties may require overtime, including nights and weekends. Position may require prolonged sitting or standing. In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance (Spouse, Child) 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 and more) Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal and more) Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union) Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities to perform the job. It may not include all duties and responsibilities. Simtra reserves the right to modify based on business needs. Simtra is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic.
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