PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The QA Engineer will estimate, plan, and coordinate investigating activities. The QA Engineer will also ensure that quality issues and defects are appropriately identified, documented, tracked, and resolved in the defect tracking system. The QA Engineer will provide statistical information for quality improvement by identifying negative trends, developing improvement strategies and assist in implementing those improvements. Function as Quality department representative on Center project teams. RESPONSIBILITIES:
- Develop and deploy quality systems, such as microbiological process controls and monitoring, design control and ensure validations conform to defined requirements.
- Evaluate process changes and implementation of new processes through risk analysis implementing appropriate mitigation activity, reducing sources of variation and improving outgoing preparation quality.
- Drive customer complaint reduction activity through root cause analysis and implementation of appropriate corrective and preventative action plans.
- As a leader and/or member of project improvement teams, apply the DMAIC improvement cycle is the core tool used to evaluate, implement change and drive Six Sigma projects. Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Drive evaluation and closure of process issues through application of the CAPA process.
- Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence and establishes statistical reliability.
- Deploy sound quality engineering processes and validation principles to assure conformance to regulatory requirements.
- Coordinate with the Operations and Training function in direct interaction with staff to assure compliance with Standard Operating Procedures.
- Develops experiments by applying full and fractional factorial techniques.
- Develops sampling plans by applying attribute, variable, and sequential sampling methods.
- Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining American Society of Quality certified quality engineer qualification.
- Contributes to team effort by accomplishing related results as needed.
- Manage/facilitate interactions with vendors and consultants concerning equipment, products, systems and processes.
- Develop and implement quality system enhancements.
- Perform other assignments as required.
- Bachelor's Degree in engineering, life sciences or related field required.
- Direct experience in FDA regulated environment, preferably drug manufacturing aseptic drug manufacturing. Aseptic processing experience required.
- Six Sigma Black Belt and experience working in a Lean manufacturing environment. Formal training and certification in LEAN Six Sigma required.
- Experience applying DMAIC principles in a regulated environment.
- Minimum of 3-5 years' experience in Quality, or related field in the healthcare or pharmaceutical industry.
- Demonstrated understanding of quality assurance in a regulated (FDA, DEA, ISO) environment.
- Thorough understanding of the Governmental requirements in a sterile processing environment.
- Computer skills in word processing, spreadsheets and databases required.
- Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills
- Analyzing Information , Reporting Research Results, Technical Understanding, Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation, CAD, Quality Engineering, Operations Research
- Ability to travel as needed, approximately 10-15%.
- Strong leadership skills; excellent verbal and written communication skills and computer skills.
- Success working with cross-functional teams; strong track record demonstrating problem-solving skills.
A little about us:
Where knowledge, reach and partnership shape healthcare delivery.