R&D Quality Specialist

Adare Pharma Solutions Recruiting Team • Vandalia, OH

19h • Onsite

About The Position

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.

Requirements

• 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.

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.

Benefits

• medical
• dental
• vision coverage
• a retirement plan with company match
• paid time off
• company holidays
• tuition reimbursement with no waiting period
• life insurance
• pet insurance
• Flexible Spending Accounts (medical and dependent care)
• disability coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees