Quality Assurance Specialist

Adare Pharma; Vandalia (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Adare Pharma Solutions is seeking a Quality Assurance Specialist in Vandalia, OH. The role focuses on auditing batch production documentation, supporting development, and overseeing Contract Manufacturing to ensure cGMP adherence.

Responsibilities include disposition of product records, deviation investigations, and maintaining quality agreements with customers and CMOs. Collaboration across departments and participation in internal audits are essential.

Qualifications

• Bachelor's degree preferred with quality experience in pharma or GMP industries.
• Experience using a Quality Management System; Veeva experience preferred.
• Experience with Microsoft Office Suite (Word, Excel, PowerPoint).
• Knowledge of cGMP related to records and documentation in bulk manufacturing.

Responsibilities

• Disposition Product: review production, packaging, and analytical records for compliance.
• Investigations: ensure deviations are properly documented and investigated, approve CAPAs.
• Interact with Customers: ensure quality agreements and confidentiality.
• Third Parties: review master and executed records with CMOs to resolve deviations.
• Projects: participate on project teams as assigned by management.
• Training: complete all assigned training by due dates.
• Audits/Inspections: participate in internal audits.
• Interface with departments: maintain professional interactions and ensure facility adherence to cGMP.

Skills

Quality Assurance

Documentation Review

Deviation Investigation

Veeva

MS Office

Education

Bachelor's Degree

Tools

Veeva

Microsoft Office

Job description

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

Quality Assurance Specialist

Location

Vandalia, OH

Summary

The Quality Assurance Specialist is key player on the Quality Assurance team, and is responsible for the audit of batch production documentation (manufacturing records, analytical records, deviation investigations), Development support, Contract Manufacturing oversight, disposition of product, approving quality documents (e.g. SOP, protocols, methods), and overall adherence to cGMP.

Responsibilities

• Disposition Product
  • Review executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards
  • Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP and resolves major issues that are not defined by SOP.
  • Conduct product release activities for intermediates, drug product and finished goods including review and approval of master batch records and executed batch records.
• Investigations
  • Ensure deviations are properly documented and investigated.
  • Approve Corrective and Preventive Actions.
• Interact with Customers
  • Ensure compliance with Quality Agreements.
  • Support customer service-related business activity, as appropriate.
  • Maintain the confidentiality of pertinent information.
• Third Parties
  • Review and approve master and executed manufacturing / packaging records.
  • Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.
• Projects:
  • Actively participates on project teams as assigned by management.
• Training:
  • Completes all assigned training by target due dates.
• Audits/Inspections:
  • Participates in internal audits as assigned by management.
• Interface with all departments within the company
  • Be an ambassador for Quality within the company
    • Maintain professional interactions with all departments and other sites
    • Ensure facility adherence to cGMP
    • Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management
    • Follow other job-related instructions and perform other tasks as required

Experience, Education, and Skills Required

• Bachelor's Degree preferred, with at least 2+ years of Quality experience in a pharmaceutical or other GMP regulated industry.
• Experience using a Quality Management System; experience with Veeva preferred.
• Experience with using the Microsoft Office Suite of software (Word, Excel, PowerPoint) is preferred.
• Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.
• Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems is highly preferred.
• Accuracy and neatness of compiling documents.
• Attention to detail.

Physical Demands

• The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is frequently required to sit, use hand and fingers, to manipulate objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to stand, walk stoop, kneel, crouch, or crawl, and talk or hear.
• Specific vision abilities required by this job include close vision, color, peripheral, depth perception and the ability to adjust focus.
• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Must have ability to wear a respirator in order to work with chemicals of a specified potency level
• Occasionally move items or equipment weighing up to 25 pounds - potential to handle heavier materials with mechanical assistance.
• Occasionally required to climb ladders and/or steps to reach equipment.
• Reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.

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.