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Senior QA Analyst - Day Shift (On-site in College Station, TX)

• **This position does support our site in College Station, TX and will require relocation to the area.The Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.Reports to Director/Senior Manager/Supervisor, Quality AssuranceWork Location College Station, TXPrimary Responsibilities:• Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:-Standard Operating Procedures-Batch Production Records (completed and approval)-Commissioning, qualification and validation protocols and reports-Deviation Reports-Corrective Action/Preventive Action Plans-Technical data review and approval-QC data review and approval-Drug Substance/Product Reports-Trending QA data• Draft and review internal Quality policies, procedures and reports.• Perform inspection of final product containers and review and/or approval of executed process records and data.• Perform Quality audit functions to include, but not limited to:-Audit of lab notebooks-Audit of equipment logbooks-Review of vendor, supplier, contract laboratory audit questionnaires-Lead vendor, supplier, contract laboratory and client audits• Identify process and Quality System improvement opportunities.• Provide daily guidance for the compliance of the QA department to national and international standards and regulations.• Support Regulatory, client, and internal audits.• Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.• Assist with technical oversight/training for the QA team.• Assist with compliance related functions.• Ensure priority task coverage.• Escalate any issues as identified to Quality Management and/or departmental Management as needed.• All other duties as assigned.Qualifications:• Master’s Degree and 3+ years of Pharmaceutical or other regulated Industry experience.• Bachelor’s Degree and 5+ years of Pharmaceutical or other regulated Industry experience.• Associate’s degree and 7+ years of Pharmaceutical or other regulated Industry experience.• Certified Quality Auditor preferred.• Degree in Biology or Chemistry preferred.• Excellent written and oral communication skills.• Excellent organizational, analytical, data review and report writing skills.• Ability to set personal performance goals and provide input to departmental objectives.• Ability to multitask and easily prioritize your work.• Ability to work independently with little supervision.• Proficient in Microsoft Excel, Word and PowerPoint.• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.• Role model for company core values of trust, delighting our customers, Gemba, and Genki.
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What You Should Know About Senior QA Analyst - Day Shift (On-site in College Station, TX), Fujifilm Diosynth Biotechnologies

If you're looking for an exciting opportunity, the Senior QA Analyst position at our College Station, TX site might be perfect for you! In this role, you'll be stepping into a key position responsible for maintaining the highest quality standards in our products. You’ll review and approve essential documentation such as Standard Operating Procedures and Batch Production Records with minimal oversight. Your keen eye for detail will be invaluable as you perform quality audits and provide critical guidance to various departments, ensuring everything runs smoothly and in compliance with national and international regulations. Collaborating with other teams, you’ll identify areas for improvement in our Quality System, and act as the primary QA liaison for internal departments and external clients. Plus, your expertise will aid in training other members of the QA team. With the chance to engage with cutting-edge processes and work on continuous improvement, you'll play a vital role in upholding our commitment to delivering quality pharmaceutical products. If you hold a Master's Degree and have at least three years of experience in a regulated environment—or have other educational backgrounds paired with relevant experience—we’d love to hear from you. Join us in making a difference while you grow your career in a supportive and collaborative environment.

Frequently Asked Questions (FAQs) for Senior QA Analyst - Day Shift (On-site in College Station, TX) Role at Fujifilm Diosynth Biotechnologies
What are the main responsibilities of a Senior QA Analyst at the College Station site?

As a Senior QA Analyst at our College Station site, your main responsibilities will include reviewing and approving technical documentation, conducting quality audits, identifying quality improvement opportunities, and serving as a point of contact for both internal departments and external clients on quality matters. You'll also draft and review internal policies and provide compliance guidance.

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What qualifications do I need to apply for the Senior QA Analyst position in College Station, TX?

To apply for the Senior QA Analyst position in College Station, TX, you should have at least a Master’s Degree with three years of experience in the pharmaceutical industry or other regulated sectors. Alternatively, candidates with a Bachelor’s degree and five years of experience, or an Associate’s degree with seven years of experience may also qualify. Certification as a Quality Auditor is preferred.

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What skills are important for the Senior QA Analyst role at the College Station location?

Key skills for the Senior QA Analyst role at the College Station location include excellent written and verbal communication, strong organizational and analytical abilities, proficiency in Microsoft Excel and Word, and a solid understanding of cGMP regulations. Additionally, the ability to prioritize tasks and work independently is essential for success in this position.

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Can I expect to work independently as a Senior QA Analyst in College Station, TX?

Yes, the Senior QA Analyst position in College Station, TX encourages independent work. You'll have minimal supervision and will be responsible for setting your performance goals while contributing to departmental objectives. However, collaboration with other teams is still vital to your success.

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What makes the College Station Senior QA Analyst position unique compared to similar roles?

The College Station Senior QA Analyst position stands out due to its emphasis on product quality and compliance in a dynamic work environment. You’ll get the chance to directly influence the quality assurance processes and engage with various departments, ensuring that the highest standards are maintained throughout the production cycle.

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Common Interview Questions for Senior QA Analyst - Day Shift (On-site in College Station, TX)
What experience do you have with quality audits in your previous QA roles?

When answering this question, provide specific examples of quality audits you have conducted, including your role, the processes you audited, and the outcomes of those audits. Highlight any improvements you implemented as a result.

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How do you prioritize tasks in a fast-paced QA environment?

Explain your time management strategies, such as using lists, setting deadlines, and how you assess the urgency of different tasks. Mention your experience working under pressure while maintaining quality standards.

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Can you describe a time when you identified a significant quality issue?

Recount a specific incident where you noticed a quality issue, describe your investigation process, the actions you took to escalate the issue, and the outcome. This shows your problem-solving skills and attention to quality.

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What is your approach to drafting and reviewing internal quality policies?

Discuss your methodology for ensuring that quality policies are compliant with regulations and reflect industry best practices. Highlight any relevant experiences where you contributed to policy development.

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How would you handle conflicts with other departments regarding quality concerns?

Share your communication strategies for resolving conflicts, emphasizing your approach to collaboration and compromise while maintaining a focus on quality objectives. Illustrate this with an example from your past experience.

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What steps do you take to stay updated on industry regulations?

Show your commitment to continuous learning by discussing the resources you use, such as industry publications, seminars, and webinars. Highlight specific certifications you’re pursuing or have obtained.

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How do you ensure compliance with cGMP regulations?

Detail your understanding of cGMP regulations and the specific practices you implement in your daily work to ensure compliance, such as record keeping, conducting audits, and training team members.

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What tools or software are you proficient in for quality assurance?

List tools and software you have experience with, like Microsoft Excel, Quality Management Systems, or specific auditing software. Provide examples of how you used these tools to enhance quality assurance processes.

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How do you manage multiple projects with competing deadlines?

Discuss your strategies for managing multiple projects, such as how you break down tasks, assign priorities, and communicate with team members to ensure all deadlines are met effectively.

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What do you think is the most challenging aspect of being a Senior QA Analyst?

Reflect on the potential challenges, such as keeping up with rapid changes in regulations, enforcing compliance across different teams, or ensuring thorough audits. Share your perspective on how you might overcome these challenges.

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At FUJIFILM Diosynth Biotechnologies our mission is to become the leading and most trusted global CDMO in the industry, and our purpose is to become Partners for Life, Advancing Tomorrow’s Medicine

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Full-time, on-site
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December 10, 2024

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