QA Operations Specialist II (906)

Essential Duties and Responsibilities

• Support operational compliance aspects of sterile fill-finish manufacturing of insulin and biologics or biosimilar small molecule products including but not limited to material, bill of material and executed batch record review and approval.
• Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
• Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
• Act as a resource for colleagues.
• Lead or participate in Quality Risk Management Processes as needed.
• Promote a safety and quality-first mindset in daily job functions.
• Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
• Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
• Support, lead, or approve documents, change controls, investigations and CAPAs to support Civicas Quality Management System.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Proactively be a team lead for department objectives with a minimal amount of supervision. Includes complex project management that may overlap with other functional areas.
• Support site objectives with a minimal amount of supervision. Includes simple project management that may involve other functional areas.
• Travel is limited but may occasionally be required.

Basic Qualifications and Capabilities :

• 6 years experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education.
• Project management, organization, and execution skills are required.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is required.
• Excellent interpersonal and written communication skills and experience using various software / electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, customer focused, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications :

• Manufacturing Batch Record Design experience is highly desirable.
• Technical expertise in sterile pharmaceutical isolator technology, combination products and medical devices is highly desirable.
• Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
30+ days ago