Quality Operations Specialist-Osmotica

Position Details

Position Title:

Quality Operations Specialist

Function:
Quality

Reports To:

Manager, Quality Operations

Location:

Marietta and/or Alpharetta, GA

Primarily responsible for ensuring compliance and accuracy of all documentation and data related to the review and disposition of manufactured / packaged product. Work closely with Production personnel to complete on-the-floor, in-process batch record review or post-executed review, resolve batch related issues, ensure proper good documentation practices, complete timely final batch record disposition to meet release scheduling. Provide quality oversight to all production areas to ensure product quality and compliance to batch record and operating procedures.

Evaluate and resolve process issues in cooperation with Production and support personnel to ensure product safety. This person works closely with operations personnel ensuring cGMP concerns are identified and resolved according to cGMP and business requirements. Perform Quality disposition processes in the appropriate systems as required.

• Required to be on-the-floor as needed to provide quality oversight for all critical manufacturing processes
• Perform QA release and line clearance inspections, AQL checks on product when necessary
• Perform Label Control functions (issuance and reconciliation)
• Conduct review of batch records and disposition of manufactured products (commercial and clinical)
• Identify deviations and ensure the appropriate personnel initiate impact assessments for investigations. Provide support and guidance in the resolution of GMP and compliance matters
• Assist in the investigation and documentation of deviations related to products, processes, and utilities. Recommend corrective actions or process improvements to eliminate the potential for future deviations.
• Clearly communicate complex issues to management
• Review Deviations, Investigations, CAPAs and Change Controls as needed
• Initiate / execute action plan requirements as needed to address investigation activities.
• Place items on Quality Hold and manage material / product rejection process
• Manage temperature and humidity excursions and monitoring
• Ensure Annual Product Reviews, Product Complaints, and Retain / Reserve Sample management systems are in compliance
• Author Product Complaint investigations, Annual Product Reviews, and other reporting functions
• Manage document completion storage, archival, electronic copies, and trackers
• Assist Production management in the revision process of master manufacturing and packaging records
• Support creation / revision of SOPs to reflect current practices
• Assist with FDA and other regulatory inspections
• Perform all activities in compliance with Osmotica Quality System, site environmental, health and safety rules; and applicable FDA and international regulations.
• Maintain knowledge of current regulatory requirements pertaining to drug product manufacture
• Manage metrics on a regular basis, as applicable.
• Perform additional duties and responsibilities as assigned.

• Bachelor’s degree in science or related field from an accredited college or university
• 3-6 years of equivalent experience with pharmaceutical or biotech GMP manufacturing.
• Proficient knowledge of GMP production facilities, manufacturing processes, and/or inspection processes
• Demonstrated understanding and application of cGMP, current industries practices and relevant guidance
• Position requires the ability to work independently, and effective skills in all areas of communication, collaboration, and decision-making
• Attention to detail with ability to work on multiple projects
• Good technical writing skills for reporting, procedures, investigations, and other documents
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency
• Computer experience required;
  Proficiency in Microsoft Office (Word, Excel, Access and Visio

• Quality Assurance experience.
• Previous experience assisting with or hosting regulatory agencies inspections
• Quality or Pharmaceutical certifications a plus.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. Employee may be required to inspect pharmaceutical equipment which includes crouching to look under equipment and/or contorting to examine difficult to view areas. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer).

Must be able to lift and move up to 20 lbs. Periodic/infrequent travel to sister sites may be required. No…