Quality Assurance Specialist

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, Ohio
Summary
The Quality Assurance Specialist 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 ensuring adherence to cGMP.

Responsibilities

• Audit Analytical testing and executed Batch Production Records.
• Review and approve Deviations and Lab Investigations.
• Coordinate and support Quality Assurance aspects of Product Development and Contract Manufacturing activities.
• Perform cleaning verification visuals and swabs.
• Release in-process materials for further processing and finished products for shipment.
• Interact with Customer’s Quality associates as necessary.
• Maintain and ensure correctness of documentation.
• Interface with all departments within the company.
• Ensure facility adherence to cGMP.
• Maintain the confidentiality of pertinent information.
• 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.
• Attends work on a regular and predictable basis.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Perform other tasks as required.

Experience, Education, and Skills Required

• Bachelor’s Degree preferred, with at 3+ years’ of Quality experience in a pharmaceutical or similarly 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.

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

Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there’s no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can’t quickly verify the identity of the poster.