Our Business
Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.”

Our Culture
When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?
Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

R& D Quality Specialist

Location

Vandalia, Ohio

Summary
The R& D Quality Specialist is a dedicated Quality resource to the R& D Department. The position is responsible for maintaining proper GMP practices in the lab through development, tracking, review, and revisions of SOP’s, lab records, and other items relating to proper compliance with regulatory guidelines in the R& D department.

Responsibilities

• Support the R& D department in developing, revising, and improving SOPs to enhance efficiency and ensure quality by design.
• Ensure compliance with Quality Systems (e.g., CAPA, Deviations/Non-Conformance, Change Control, Data Integrity, Complaints, and Trending) within R& D.
• Assist in tracking CAPAs and ensuring timely implementation, closure, and effectiveness.
• Review master batch records for non-commercial GMP batches (e.g., clinical and tech transfer batches).
• Review and provide input on Design of Experiments (DoE), Critical Process Parameters (CPP) reports, and other technical documentation.
• Review quality-related R& D documentation such as sampling protocols, stability protocols, method qualification/validation reports and master batch processing records.
• Support and/or participate in investigations, including root cause analysis and documentation.
• Participate in internal audits of the R& D department and support audit readiness activities.
• Collaborate cross-functionally with R& D, QA, Manufacturing, and other departments to ensure compliance with cGMP and SOPs.
• Support interactions with customers and assist during client or regulatory audits as needed.
• Maintain compliance with controlled substance procedures, including inventory support and documentation (as applicable).
• Support Stability program as needed.
• Perform other duties as assigned.

Experience, Education, and Skills Required

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, or related field).
• 3+ years of relevant experience in a GMP-regulated pharmaceutical or related environment.
• Working knowledge of GMPs, with exposure to clinical/pre-commercial GMPs preferred.
• Familiarity with Quality Systems (CAPA, deviations, change control, etc.).
• Strong attention to detail and document review skills.
• Ability to manage multiple tasks and priorities with moderate supervision.
• Strong organizational, communication, and collaboration skills.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES