QC Scientist II

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Salary: $70,000 - $110,000 per year

We are currently seeking a dynamic and highly motivated QC Scientist II for our manufacturing industry. The successful candidate will play a pivotal role in our quality control department, ensuring that our products meet the highest quality standards. This is a permanent position offering a unique opportunity to work on a wide range of projects and products, contributing to the overall success of our company.

• Amazing Benefits
• Opportunity for growth

Responsibilities:

As a QC Scientist II, you will have a broad range of responsibilities. These include:

1. Developing and implementing quality control procedures in line with cGMP regulations.
2. Utilizing the LIMS system for data management and reporting.
3. Performing chemical analysis using techniques such as HPLC to ensure product quality.
4. Drafting, reviewing, and updating SOPs to ensure they are up-to-date and compliant with industry standards.
5. Participating in Change Control and Validation activities to ensure processes are effective and efficient.
6. Working closely with the formulation team to ensure product consistency and quality.
7. Conducting root cause analysis and implementing corrective actions (CAPA) in response to product or process non-conformities.
8. Collaborating with CDMO partners to ensure seamless transfer of technology and processes.
9. Contributing to IND and CMC documents to support regulatory submissions.
10. Maintaining a safe and clean work environment in accordance with company policies and procedures.

Qualifications:

To be considered for the QC Scientist II position, you will need the following qualifications:

1. A minimum of a Bachelor’s degree in Chemistry or a related field.
2. A minimum of 5 years of experience in a QC Scientist role in the pharmaceutical or biotech industry.
3. Proven experience with quality control, formulation, cGMP, and the LIMS system.
4. Demonstrated experience with Change Control and Validation.
5. Proficiency in chemical analysis techniques, particularly HPLC.
6. Experience in drafting and creating SOPs, including clinical SOPs.
7. Familiarity with CMC, CDMO, IND, and CAPA processes.
8. Excellent problem-solving skills and attention to detail.
9. Strong written and verbal communication skills.
10. Ability to work effectively both independently and as part of a team.

This is an exciting opportunity for a QC Scientist II to join a forward-thinking company that values innovation and quality. If you have the necessary skills and experience, we would love to hear from you.

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