Pharma QA Specialist: Ensure Safe, Compliant Drug Releases

Adare Pharma Solutions; Troy (OH); On-site; USD 60,000 - 90,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist to join the QA team. You will audit batch production documentation, review master and executed records, and ensure cGMP compliance across manufacturing and packaging processes.

The role requires a bachelor’s degree and at least 2 years of quality experience in pharma or GMP settings, with familiarity in Veeva QMS and MS Office. Strong attention to accuracy and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in a pharmaceutical or GMP-related field.
• At least 2+ years of quality experience in pharma or GMP industry.
• Experience with cGMP records and documentation.
• Knowledge of large processing systems and quality records is preferred.
• Attention to accuracy and neatness in document compilation.

Responsibilities

• Disposition Product
• Review executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards
• Resolve documentation issues as directed by SOP and resolve major issues 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
• Maintain the confidentiality of pertinent information
• Review and approve master and executed manufacturing / packaging records
• Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition
• Actively participates on project teams as assigned by management
• Completes all assigned training by target due dates
• 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

Skills

Quality experience

Veeva

MS Office

Education

Bachelor’s degree (B.S. or B.A.) in a relevant field

Tools

Veeva Vault

Microsoft Office

Job description

Adare Pharma Solutions in Vandalia, OH is seeking a Quality Assurance Specialist to join the QA team. You will audit batch production documentation, review master and executed records, and ensure cGMP compliance across manufacturing and packaging processes.

The role requires a bachelor’s degree and at least 2 years of quality experience in pharma or GMP settings, with familiarity in Veeva QMS and MS Office. Strong attention to accuracy and cross-functional collaboration are essential.