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- Tasks: Lead quality control for raw materials, ensuring compliance and accuracy in testing.
- Company: Join a dynamic CDMO focused on pharmaceutical quality and innovation.
- Benefits: Competitive salary, career growth, and a supportive work environment.
- Other info: Collaborative team atmosphere with opportunities for professional development.
- Why this job: Make a real impact in the pharmaceutical industry while developing your leadership skills.
- Qualifications: BA/BS in a scientific field with 5+ years of supervisory experience.
The predicted salary is between 50000 - 60000 £ per year.
The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients.
Essential Functions
- Author or act as author for lab investigations, deviations, protocols and specifications for raw materials.
- Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
- Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
- Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements.
- Interact with third party laboratories for microbial and analytical testing of raw materials.
- Generate and/or review shipping paperwork for third party testing and prepare samples for shipment.
- Create purchase requisitions for lab supplies and third-party testing.
- Perform weekly laboratory audit inspections.
- Perform sampling of raw materials as needed.
- Review third party laboratory investigations and protocols.
- Provide technical support to the laboratory for method and instrument troubleshooting as needed.
- Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques.
- May perform testing of raw materials, packaging components, and other samples as needed.
- Other duties as assigned.
Supervisory responsibilities:
- Direct Reports: Yes
- Indirect Reports: None
Key Relationships:
- Manufacturing Operations
- Quality Assurance
- Analytical R&D
- Program Management
Travel requirements: None
Education and Experience
- Minimum BA or BS in a scientific discipline required.
- Minimum of 5 years of prior supervisory experience.
- Minimum 5-7 years in an Analytical development or Quality Control setting for Pharmaceutical Products or Raw Materials preferred.
- Experience establishing and maintaining relationships with key decision makers.
Knowledge, Skills, and Abilities
- Knowledge of cGMPs.
- Good communication, organization and computer skills are required.
- Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired.
- Ability and willingness to work additional hours as required by business need.
- At least 5 years’ experience in a CRO environment.
- Experience with USP, EP and JP monographs.
- Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size.
- Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders.
- Excellent verbal and written communication skills.
- Ability to work with minimal supervision.
- Experience in Data Review of Analytical data per GDP guidelines.
- Proven ability to review and evaluate the compliance and completeness of analytical data.
- Able to multi-task productively, applying time management processes and procedures effectively.
- Works toward common goals by supporting, encouraging, and sharing information with colleagues.
- Strong analytical skills and ability to understand business and financial implications of contracts.
- Self-directed.
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position. Requires frequent sitting and walking. Requires carrying under 20 LBS, occasionally 20 – 60 LBS. Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS. Requires occasional bending, twisting, reaching, & gripping. Requires constant seeing & hearing.
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
QC Manager, Raw Materials in Durham employer: MedPharm
Contact Detail:
MedPharm Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QC Manager, Raw Materials in Durham
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in QC or related fields. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and analytical techniques. We want you to shine when discussing your experience with HPLC, GC, and other lab equipment during those crucial conversations.
✨Tip Number 3
Don’t forget to showcase your communication skills! Practice explaining complex concepts in simple terms, as this will be key when presenting to clients or collaborating with teams. We know you’ve got it in you!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and eager to join our team. Let’s get you that QC Manager role!
We think you need these skills to ace QC Manager, Raw Materials in Durham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QC Manager role. Highlight your experience in GMP environments and any supervisory roles you've held. We want to see how your skills match up with what we're looking for!
Show Off Your Communication Skills: Since communication is key in this role, don’t forget to showcase your verbal and written communication skills in your application. Give us examples of how you've effectively interacted with clients or team members in the past.
Be Specific About Your Experience: When detailing your experience, be specific about your knowledge of cGMPs and any relevant laboratory equipment you've worked with. We love seeing concrete examples that demonstrate your expertise!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at MedPharm
✨Know Your GMPs Inside Out
Make sure you brush up on your knowledge of current Good Manufacturing Practices (cGMPs). Be ready to discuss how you've applied these regulations in your previous roles, especially in a Quality Control setting. This will show that you understand the importance of compliance and can navigate the complexities of a GMP environment.
✨Showcase Your Communication Skills
Since this role requires superior communication skills, prepare examples of how you've effectively communicated with both internal teams and external clients. Think about times when you had to present complex data or findings clearly and concisely. Practising these scenarios can help you articulate your thoughts during the interview.
✨Familiarise Yourself with Analytical Techniques
Get comfortable discussing the laboratory equipment and techniques mentioned in the job description, like HPLC, GC, and FTIR. If you have hands-on experience, be prepared to share specific examples of how you've used these tools in your work. This will demonstrate your technical expertise and readiness for the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities, especially regarding lab investigations and deviations. Think of past experiences where you successfully resolved issues or improved processes. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easier for the interviewer to follow your thought process.