GMP Compliance & Training Specialist

Works closely with the Manufacturing and Quality Departments to ensure GMP and 6S compliance in the production of commercial and developmental products.

Essential Functions:

• Ensures GMP compliance in Manufacturing, Quality and R&D.
• Ensure training compliance for all functional groups; works with functional group leaders on any required qualification training.
• Routinely conducts training sessions with operations or other functional groups as required by quality system actions or for general improvement initiatives.
• Lead in scheduling and follow-up for routine ARx walk throughs of the manufacturing, laboratory, and warehouse areas to ensure GMP and 6S compliance.
• Review of in process documentation in manufacturing and analytical areas for compliance to ARx good documentation practices and effective procedures.
• Dedicates a minimum of 50% of time to maintaining a physical presence inside the ARx manufacturing suites during production across all shifts.
• Build, maintain, and execute ARx internal audit schedule as per ARx effective procedures.
• Prepare and present monthly report outs to area functional leaders including any recommended process or training improvements. Immediately report out any GMP compliance or 6S deficiencies to supervisor.
• Assist as a backup for operations for any manufacturing signoffs or approvals as needed.
• Assist in line clearance as required,
• Assist in quality inspection and sign off of manufacturing equipment as needed per standard operating procedures.
• Participates in internal and/or external audits (e.g. client, FDA, DEA, etc.), as required.

Additional Responsibilities:

• Acts as backup for QA batch record and document issuance.
• Comply with all Corporate Safety policies.
• Perform other duties and responsibilities as assigned by supervisor.

Job Specifications:

• Requires bachelor’s degree in technical or engineering discipline and/or a minimum of 5 years of quality experience in Quality Systems; working knowledge of cGMP and GLPs. Evidence of continuing education such as professional certification (ASQC) desired.
• Ability to perform required duties independently, efficiently, and effectively with minimal supervision.
• Able to use initiative in carrying out assignments independently without specific instructions; exercises sound judgment and discretion regarding when to request guidance and/or assistance from others.
• Ability to thoroughly review documents for accuracy and completeness.
• Ability to read and interpret documents such as test methods and procedure manuals.
• Ability to work with mathematical concepts such as averages, standard deviation, and other basic statistical functions.
• Ability to operate computers and other office equipment; software packages (e.g. Oracle, MS-Outlook, MS-Excel, MS-Word, Minitab, PDFs, SharePoint, scanning, etc.) competence for drafting documents as well as inputting, tabulating and retrieving data.
• Work environment can involve moderate risks or discomforts requiring special safety precautions, may be required to use personal protective equipment.
• Ability to maintain confidentiality of company and client information.
• Ability to conduct duties and interact with others (colleagues & external parties) in a professional manner.
• Ability to understand and conform to Company policies and procedures.
• Ability to spend time in manufacturing environment across all three shifts.