Quality Control Stability Senior Scientist 503B- East Windsor, NJ

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Job description

Position Summary:
The Quality Control (QC) Stability Senior Scientist plays a critical role in leading Empower's stability program, ensuring compliance with current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) guidelines. This position oversees the execution of stability protocols, manages sample testing, and ensures timely reporting, working closely with cross-functional teams to support quality and regulatory requirements. By driving the stability program, the Senior Scientist directly supports Empower's mission of providing high-quality, affordable medications that improve lives.

Duties and Responsibilities:
Leads stability program and testing activities to meet critical deliverables and timelines.

Ensures the stability program adheres to Standard Operating Procedures, cGMP, and ICH guidelines, while overseeing protocol drafting, sample management, reporting, coordinating with external testing facilities, and participating in audits and investigations.

Ensures stability chambers are maintained in a calibrated and qualified state per guidelines, coordinating with external storage facilities for sample shipping, progress tracking, and timeline monitoring as needed.

Works closely with QC chemists to ensure timely execution of stability protocols, study initiation, time point pulls, testing, and reports, while collaborating with QC-Chemistry, QC-Microbiology, Quality Assurance, Manufacturing, and other cross-functional teams for stability studies.

Proactively plans and communicates annual stability requirements, follows stability protocols to meet timelines, accurately pulls samples, coordinates testing, and ensures timely compilation and communication of reports.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:
Proven ability to work independently, manage multiple tasks, and meet deadlines while handling analytical instrumentation in a GMP-regulated environment, with strong attention to detail, proficiency in Microsoft Office, and knowledge of ICH stability guidelines.

Strong understanding of FDA and cGMP requirements, with preferred 503B experience, skilled in safety procedures, documentation, and proficient in communication and statistical software for stability testing.

Key Competencies

Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.

Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.

Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.

Resourcefulness: Secures and deploys resources effectively and efficiently.

Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.

Ensures Accountability: Holds self and others accountable to meet commitments and objectives.

Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.

Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.

Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.

Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.

Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications:
Requires a Master's degree in a scientific discipline such as Biology, Chemistry, Microbiology or equivalent with a minimum of 4 years of experience in a QC laboratory in a Food and Drug Administration (FDA) regulated environment, or

A Bachelor's degree in scientific discipline such as Biology, Chemistry, Microbiology or equivalent with a minimum of 6 years of experience in a QC laboratory in an FDA-regulated environment.

Benefits:
No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.

Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.

Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.

Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.

Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.

Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.

Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.

FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).

401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.

Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.

Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.

Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck.

Additional Voluntary Benefits

Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.

Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.

Critical Illness: Protect your finances from the expenses of a serious health issue.

Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.

Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.

Legal Services: Access professional legal assistance to address concerns confidently.

Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.

Pet Insurance: Care for your furry family members with our pet insurance coverage.

Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.

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