Quality Assurance Manager (Oral Solid Dose)
|Monroe, North Carolina - United States
$80,000.00 - $110,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Assurance Manager, Oral Solid Dose to join our growing team. The Quality Assurance Manager maintains oversight of assigned cGMP areas to ensure compliance with company policies and procedures, as well as applicable regulatory requirements. The Quality Assurance Manager directs a team of In-Process Quality Assurance (IPQA) staff to provide a presence and oversee all Quality aspects of pharmaceutical manufacturing, including, but not limited to: warehousing, dispensing, manufacturing, packaging, and batch disposition. The IPQA team provides immediate direction for potential Quality issues on the production floor, including first assessment of potential deviations and initial determination of product impact and immediate corrective actions, including the management of product, equipment and facility systems. The Quality Assurance Manager is responsible for providing Quality Assurance oversight in the production process, ensuring that products, materials, batch records and labeling are properly managed according to cGMP and other internal and external regulations and standards. The Quality Assurance Manager is responsible for partnering site management of all areas to drive the Quality culture and mindset at the site.
Responsibilities include but not limited to:
- Ensure regulatory / statutory compliance is regularly monitored and remains in a state of compliance, as applicable.
- Maintain quality system controls to reduce likelihood of customer / product complaints attributable to Quality and Safety of the product, as applicable.
- Take appropriate steps to build improved efficiency in IPQA activities throughout the product life cycle, as applicable.
- Align with site goals and ensure IPQA staff is supporting Quality, Compliance and Production objectives, focused on Quality throughput and Safety of personnel.
- Provide strategic direction to the IPQA group in alignment with site and Quality department objectives, to ensure that business and compliance needs are met.
- Provide leadership, mentoring and development opportunities for the IPQA Specialists / staff.
- Ensure IPQA Specialists / staff are appropriately trained and aligned to support OSD area production activities.
- Ensure IPQA Specialists / staff are available and active in first response to OSD area product quality issues for all shifts.
- Ensure components / materials proceed through the proper disposition and are properly dispensed per requirements.
- Ensure Line Clearance activities are properly executed prior to commencement of manufacturing and during change over.
- Ensure status of equipment, utilities and production areas are in a state of acceptance and maintained / labelled accordingly
- Ensure manufacturing areas are maintained per cGMP.
- Perform sampling of In-process, Finished Product, Stability and Retention samples, as directed / per requirements.
- Perform real-time review of batch process and Batch Records.
- Ensure the manufacturing process is executed per established Batch Records and effective procedures.
- Perform final review / disposition activities for Finished Product.
- Responsible for IPQA oversight and Quality coordination with responsible stakeholders for activities in the OSD area.
- Assist in the execution and responses for externally-driven inspections and internal audits.
- A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required.
- Advanced degrees may be used to reduce required experience.
Minimum of 8 years of experience required in Quality or Design Assurance in the Pharmaceutical, Biotech, or Medical Device industry, with technical expertise in Oral Solid Dosage manufacturing a plus
- Significant experience/knowledge of the following:
- Regulations and Guidelines (e.g., CFR, ICH, USP, etc.)
- Regulatory Inspections
- Change Control/Management
- Deviations/Non-Conformances and CAPA
Knowledge & Skills:
- Proficiency with Microsoft Word, Excel and PowerPoint is required.
- Experience with SAP or other ERP system is highly desired.
- Experience with electronic Documentation/Quality Management system is desired.
- Strong communication and documentation skills are required.
- Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
- Must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.
- Lean Six Sigma experience preferred. Green Belt highly desired.
- Certified Quality Auditor (CQA) or Engineer (CQE) is a plus.
University - Bachelor's Degree/3-4 Year Degree