Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy
Jobs / Job page
QA Specialist, QA for QC image - Rise Careers
Job details

QA Specialist, QA for QC

Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become a participant in the further establishment and effective operation of the QA Commercial department. You are offered a position with potential to grow your professional and personal skills and to be part of the handling of new products and new markets. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

As QA Specialist, QA for QC, you will be part of a dynamic and competent team contributing to the development of the QA for QC capabilities and get the opportunity to contribute with your knowledge and experience.

Your role will specifically focus on QA oversight of our outsourced analytical testing for starting materials, intermediates, drug substances and drug products. You will support and conduct review and approval of i.e., analytical documentation, relevant quality system records such as deviations, change controls and CAPAs and other operational related documentation.

Moreover, you will contribute actively in upgrades of quality systems and SOPs, launch activities, quality management reviews, etc. Finally, you will work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes. Your role may expand to cover CMO oversight activities in general.

Ascendis Pharma is a virtual biotech company that works with CROs and CMOs worldwide. Therefore, it is crucial you appreciate the elements necessary to provide excellent external supplier management and oversight, as well as support the organization in establishing/maintaining relevant quality processes.

Main areas of responsibility:

  • Review and approval of analytical documentation from CMOs and/or testing laboratories, including but not limited to laboratory records, deviations, laboratory investigations, OOS/OOT/OOE, changes, CAPAs, analytical method validation and stability protocols and reports, etc.
  • Support commercial Ascendis Pharma quality management review process, annual product quality reviews, and other projects that the department is involved in.
  • Participate as needed in inspections and internal and external audits in Ascendis Pharma.
  • Communication with key personnel at CMOs, including face-to-face and online meetings.
  • Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs.

You have minimum 5-10 years’ experience from Quality Assurance and/or Quality Control within the life science industry. Preferably, you have solid experience with commercial operations, participation in various projects as a QA representative. You have good experience with regulatory expectations and guidelines for analytical methods. Furthermore, you are competent within stakeholder management, including oversight of outsourced activities, and have a good business understanding.

You have a master’s degree preferably in pharmacy or other relevant natural sciences. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are meticulous with a high level of attention to details. You are clear and persistent in your expectations and requirements to quality, while at the same time being pragmatic and flexible in your approach. You are self-motivated and able to work independently and finally you can communicate clearly, both internally and externally towards CMOs and other stakeholders. You ensure progress and take responsibility in agreed tasks and matters.

Travelling: Approx. 5-15 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

Hiring manager is QA Director, Jan Jakobsgaard. However, for more details about the job or the company, please contact QA Senior Manager, Christian Borch Hansen, M +45 40427787. Applications must be submitted in English and are treated confidentially. All applications will be evaluated early February 2025.

Ascendis Pharma Glassdoor Company Review
2.5 Glassdoor star iconGlassdoor star icon Glassdoor star icon Glassdoor star iconGlassdoor star icon
Ascendis Pharma DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Ascendis Pharma
Ascendis Pharma CEO photo
Jan Møller Mikkelsen
Approve of CEO

Average salary estimate

$90000 / YEARLY (est.)
min
max
$80000K
$100000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About QA Specialist, QA for QC, Ascendis Pharma

If you’re ready to make a difference in the biotech field, Ascendis Pharma A/S is looking for a passionate QA Specialist, QA for QC, to join our vibrant team! In this role, you’ll play a crucial part in the establishment and smooth operation of our QA Commercial department. Picture yourself collaborating with skilled colleagues while managing exciting new products and exploring new markets. As a QA Specialist, your primary focus will be on ensuring quality oversight of our outsourced analytical testing, which includes everything from starting materials to finished drug products. You won't just be reviewing analytical documentation; you’ll be the backbone of our quality systems, assessing deviations, change controls, and CAPAs while also actively enhancing our SOPs and quality management reviews. At Ascendis, we highly value your expertise in maintaining stellar relationships with our Contract Manufacturing Organizations (CMOs) worldwide, as you’ll need to stay ahead of regulatory changes and promote continuous improvement in quality processes. With a commitment to excellence, our environment is dynamic yet supportive, encouraging professional growth. Your background should include 5-10 years in Quality Assurance or Quality Control within the life sciences industry and a master’s degree in pharmacy or a related scientific field. A meticulous eye for detail, clear communication skills, and a knack for stakeholder management will set you up for success. If you’re looking to contribute your talents to a company that values innovation and quality in healthcare, Ascendis Pharma is where you belong!

Frequently Asked Questions (FAQs) for QA Specialist, QA for QC Role at Ascendis Pharma
What are the key responsibilities of a QA Specialist, QA for QC at Ascendis Pharma?

In the role of QA Specialist, QA for QC at Ascendis Pharma, your primary responsibilities will include reviewing and approving analytical documentation from CMOs and testing labs, managing quality systems, and participating in audits. You will also support quality management reviews and maintain excellent relationships with CMOs, ensuring adherence to regulatory guidelines.

Join Rise to see the full answer
What qualifications do I need to apply for the QA Specialist, QA for QC position at Ascendis Pharma?

To apply for the QA Specialist, QA for QC position at Ascendis Pharma, you should have a master's degree in pharmacy or other relevant natural sciences, along with a minimum of 5-10 years of experience in Quality Assurance or Quality Control within the life sciences industry, particularly in commercial operations.

Join Rise to see the full answer
How does the QA Specialist, QA for QC role interact with CMOs at Ascendis Pharma?

As a QA Specialist, QA for QC, you will be actively communicating with key personnel at CMOs through various channels, including face-to-face meetings and online discussions. Your role will emphasize oversight of outsourced activities and ensuring compliance with cGMP and regulatory standards.

Join Rise to see the full answer
What kind of experience is preferred for the QA Specialist, QA for QC position?

Preferred experience for the QA Specialist, QA for QC role includes solid knowledge of regulatory expectations for analytical methods, stakeholder management, and experience in commercial operations as a QA representative. It is crucial to understand both quality processes and business implications.

Join Rise to see the full answer
What is the work environment like for a QA Specialist, QA for QC at Ascendis Pharma?

At Ascendis Pharma, you will be part of a supportive and dynamic team located at our office in Tuborg Havn, Hellerup. The culture fosters professional growth and collaboration, and you will have the chance to work on exciting projects that advance our product pipeline.

Join Rise to see the full answer
Common Interview Questions for QA Specialist, QA for QC
Can you describe your experience with quality oversight for outsourced activities?

Highlight your experience in overseeing outsourced quality operations by discussing specific projects or instances where you successfully managed CMOs. Provide examples of how you ensured compliance with quality and regulatory standards.

Join Rise to see the full answer
What strategies do you use to maintain effective communication with CMOs?

Discuss the importance of regular meetings, clear documentation, and setting expectations. Explain how you tailor your communication style to meet the needs of different stakeholders.

Join Rise to see the full answer
How do you approach reviewing analytical documentation?

Detail your systematic review process, emphasizing thoroughness and attention to detail. Talk about the key elements you focus on, such as accuracy, compliance with regulatory standards, and documenting your findings.

Join Rise to see the full answer
What challenges have you faced in quality management and how did you overcome them?

Share specific examples of quality challenges you've encountered and the steps you took to resolve these issues. Emphasize your problem-solving skills and commitment to maintaining high quality.

Join Rise to see the full answer
How do you stay current with regulatory guidelines and quality processes?

Discuss your methods of staying updated, such as attending conferences, following industry publications, and networking with peers. Mention how this knowledge impacts your work as a QA Specialist.

Join Rise to see the full answer
What is your experience with CAPA processes?

Describe your role in initiating, investigating, and managing CAPAs. Provide an example where your actions led to quality improvements based on CAPA findings.

Join Rise to see the full answer
Can you explain the importance of cGMP in your role?

Discuss the critical role of cGMP in ensuring product quality and safety. Explain how you integrate cGMP principles into your daily tasks and oversight functions.

Join Rise to see the full answer
How do you handle discrepancies or deviations in documentation?

Talk about your systematic approach to investigating discrepancies, documenting findings, and implementing corrective actions. Emphasize your attention to detail and process-driven mindset.

Join Rise to see the full answer
What tools or software have you used in quality assurance?

Mention specific quality management systems or software you have experience with and how they have enhanced your efficiency in managing quality processes and documentation.

Join Rise to see the full answer
How do you prioritize tasks in a fast-paced QA environment?

Explain your prioritization methods, such as assessing task urgency and impact on quality. Discuss how you balance multiple responsibilities while ensuring compliance with quality standards.

Join Rise to see the full answer
Similar Jobs
Posted 14 days ago
Photo of the Rise User
Owlchemy Labs Remote No location specified
Posted 13 days ago
Photo of the Rise User
Posted 13 days ago
Photo of the Rise User
Raising Cane's Hybrid 6800 Bishop Rd, Plano, TX 75024, USA
Posted 3 days ago
Posted 7 days ago
Photo of the Rise User
ServiceNow Remote Building A,B,C 2225 Lawson Lane, Santa Clara, California, United States
Posted 12 days ago
Inclusive & Diverse
Mission Driven
Rise from Within
Diversity of Opinions
Work/Life Harmony
Empathetic
Feedback Forward
Take Risks
Collaboration over Competition
Medical Insurance
Dental Insurance
Vision Insurance
Mental Health Resources
Life insurance
Disability Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Conferences Stipend
Paid Time-Off
Maternity Leave
Equity
Photo of the Rise User
2Brains Remote Latinoamérica
Posted 13 days ago
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
December 21, 2024

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!