Quality Assurance Specialist

Quality Assurance Specialist

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.

Principals Only No Agencies Or Third Parties