The site specializes in contract manufacturing of liquid and lyophilized small volume parenteral products using aseptic processing technology, to deliver high quality sterile products to the pharmaceutical industry. The site offers value added services to assist customers in the development and manufacture of a variety of sterile products and is responsible for achieving positive P/L targets, and has consistently delivered earnings and growth to the parent company.
Customers range from mid-tier companies, biotech, biologic, and virtual pharmaceutical development organization to large billion dollar multinational pharmaceutical corporations. Product manufacturing includes the developmental cycle for injectable drugs from NDA & ANDAs, new formulations, drugs in clinical trials, stability studies and commercial products in the generic, prescription and OTC markets.
Quality Assurance is responsible for GMP Compliance of the facility. The department generates, reviews, and approves regulated, controlled documents including but not limited to SOPs, Master Batch Records, Master Packaging Records, Regulatory Filings, Change Control Requests, and Validation Protocols. The department manages the Change Control System, Quality Assurance Documentation, Regulatory Affairs, Compliance, and Validation. Additionally, this functional group is the primary Quality contact for all external and internal customers with respect to quality systems, quality process improvements, quality audits/complaints, and regulatory compliance.
Primary responsibility is coordinating, executing and providing leadership and core competencies for the Quality Engineering group to ensure provision of reliable quality systems and performance metrics and provide specialized assistance for data reporting and analysis. Coordinates improvement activities throughout the operation of the PTS Quality Assurance function a
as related to all products and customers.
Serves as analytical and technical Quality Engineering and Statistical Analysis resident expert. Contributes to core values of Quality, Timeliness, Communication and Profitability.
Essential Duties and Responsibilities:
• Ensuring that Performance Metrics are available and reported both to site and corporate management by ensuring high-level administration of required Quality Systems such as Trackwise, Eduneering, Documentum, Empower and other lab system software.
• Manage and lead improvement projects when undesirable trends are identified and lead process improvement projects to reduce # PRs.
• Process Improvement efforts related to both Quality Systems, Manufacturing Quality and Operations to ensure Operational Excellence and continuous improvements.
• Provide Risk based process controls – (utilization of Process Analytical Technology (PAT), and Failure Modes and Effects Analysis (FMEA). Provide training and implementation of use of Statistical Analysis, FMEA and root cause tools.
• Provide statistical analysis support to the organization by way of performing data analysis to determine product conformity when needed, development of statistical sampling plans, and overall technical and science based approach to process control and problem solving.
• Provide Training on Quality tools, Six Sigma, Sampling, Statistics, Root Cause Analysis, FMEA, Control plans, Design of Experiments
• Manage and Improve data collection and analysis across organization to understand where problem areas lie, process capabilities and enable process improvements such as implementing a statistical process control (SPC) database for filling operation, analysis of particulate lab data, and analysis of calibration failures to determine any preventive actions that may affect product.
• Manage, lead and/or conduct Six Sigma DMAIC, Lean and DFSS projects, leading teams to address business process problems and design new processes to achieve results.
• Facilitate problem-solving Kaizen events and WorkOut sessions to lead teams to address issues not requiring the DMAIC approach
• Mentor Green Belts in completing DMAIC projects
• Instruct Six Sigma training classes for Green Belts and “just in time” training as needed
• Conduct special data analysis projects as requested by management
• Identify opportunities for Six Sigma projects and conduct analysis to scope projects
• Coach operations managers to establish performance measurement systems and goals aligned with organizational objectives
• Establish Statistical Process Control charts where applicable and train process owners in their proper use
• Work with process owners and IT resources to make data available to process owners and Green Belts for process improvement
• Provide technical and statistical expertise to teams to enhance quality of services/ products
• Communicate frequently with Master Black Belt and Champions regarding project status, issues and accomplishments
• Other duties as assigned
This job has no supervisory responsibilities.
Education and/or Experience:
Requires a Bachelor’s degree in an engineering or scientific discipline, such as chemical engineering, industrial engineering, or mechanical engineering. This position requires at least 7-10 years of industrial experience dealing with similar systems and managing projects similar in scope and size. Minimum of 15 years directly related pharmaceutical or medical device experience. Strong background in process improvements. Familiar with Quality tools such as Statistical Analysis, SPC, FMEA, DOE, etc Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly. Ability to speak effectively. Mathematical Skills:
Ability to apply basic math concepts. Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Computer Skills:
Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software. Other Skills and Abilities:
Must have a good understanding and working knowledge of statistical process control, cost of quality tracking and other TQM tools. Strong problem-solving skills, technical judgement, and initiative to implement process improvements. Root cause analysis trouble-shooting experience. Knowledge of aseptic processing technique. Ability to train and advise QA professionals and production personnel. Knowledge of quality, regulatory and legal standards including USP, EP, JP, GMP, EPA, OSHA, ICH, DEA
and FDA. Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations. Provides leadership in data analysis and metrics and interpretation as the resident QA expert at site and among departmental staff. Must have demonstrated ability to work independently and as a team leader. Must show innovative development techniques and strategic thinking abilities.
Proficient in Microsoft Office Tools: Excel, Access, Word, PowerPoint and Visio and Minitab Software.
Other Qualifications: Must pass background check Must pass drug screen
Physical Demands: While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
Work Environment: While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate. All interested applicants must apply online.
To apply for this job please visit pharmaboard.com.