Quality Assurance Analyst

Position Summary

The Quality Assurance Specialist will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations including technology transfers within the External manufacturing realm. The Quality Assurance Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Performs all responsibilities in accordance with company policies, procedures, and regulations.

Principal Responsibilities

1. Serving as Quality Assurance support and SME for Drug Substance, Drug Product and maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.
2. Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
3. Providing oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs.
4. Working closely to build relationships with contract manufacturers quality personnel.
5. Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
6. Reviewing contractor documents i.e., Batch records, deviations and change controls to ensure that they comply with procedures and meet standards.
7. Approving specific standard operating procedures and controlled documents issued by contract manufacturing organizations.
8. Supporting contract manufacturing organization audits, including pre-approval inspections.
9. Developing and issuing quality metrics pertaining to the process quality activities.
10. Reviewing and assessing deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
11. Reviewing Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
12. Supporting Quality Assurance to guide various projects and technical meetings, as needed.

Qualifications:

1. Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
2. Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry.
3. Experience working with contract manufacturing organizations.
4. Experience working with small molecules preferred.
5. Ability to provide project leadership and guide successful completion of Quality projects.
6. Excellent written and verbal communication and negotiating skills.
7. Risk assessment and risk management.

Education:

1. Bachelor’s degree required. Advanced degree a plus.

Competencies:

1. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
2. High level technical skills including quality risk management, auditing and pharmaceutical manufacturing. Technical writing skills required.

Our Commitment to You:

At Innovative Development, LLC we value our employees and invest in their personal and professional growth. We offer comprehensive Medical, Dental and Vision options along with fully paid Life, Disability and Accident insurance. Our Employer matched 401(k) enables us to invest in your financial future, while our personalized Leadership Development program helps you thrive in your professional environment. In this fast-changing world, we prioritize mental health through our Employee Assistance Programs. We also encourage work/life balance by offering a variety of working arrangements, including remote, in-person, and hybrid. Join Innovative Development, LLC and develop your potential!

Benefits Highlights

1. PTO
2. Medical, Dental, and Vision. Health Savings accounts for qualified expenses under HSA plans.
3. Teledoc, Weight Loss and Wellness Plans included with Health Plans.
4. Employee Assistance Programs including Mental Health.
5. Employer paid life insurance.
6. Employer paid Long and Short Term Disability Coverage.
7. 401(k)/Roth IRA with Employer Matching.
8. Personalized Leadership Development Program.
9. Volunteer and Community Events.
10. Opportunity for growth.

Actual compensation will depend on a variety of factors, including geographic location, on-site requirements, qualifications, and experience.

Innovative Development, LLC is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.