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Summary: The Quality Assurance Department 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.  We offer value added services to assist customers in the development and manufacture of a variety of sterile products. The Quality Assurance Department implements all procedures leading to compliant, valid, and documented release of drug, biologic product, or medical device by performing the following duties personally or through subordinate specialists. The site is responsible for achieving positive P/L targets, and has consistently delivered earnings and growth to the company. Customers range from mid-tier companies, biotechnical, biological and virtual pharmaceutical development organizations 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. The Quality Assurance (QA) department is responsible for directing the development, implementation and maintenance of quality assurance standards, methods and procedures, as well as, quality control systems to ensure the precision, accuracy and reliability of company services in accordance with quality specifications, FDA requirements and cGMP Essential Duties and Responsibilities:
• Lead GMP deviation investigations.
• Conducts timely information gathering sessions with Manufacturing, Laboratory or Packaging/Inspection/Warehouse personnel to obtain required information and data to complete an investigation
• Assess and document product impact within the investigation
• Conduct thorough root cause analysis and document within the investigation including causal factors identified and any root causes determined
• Based on root cause outcome, identify and initiate appropriate corrective actions (CAPAs)
• Complete accurate and thorough historical searches within deviation database to identify any similar events and determine if a trend exists or is developing.
• Position requires technical writing capabilities to create clear, concise investigations with appropriate details.
• Position requires knowledge of aseptic fill manufacturing operations, lyophilization and terminal sterilization processes, supporting laboratory testing, and finished product packaging and inspection processes.
• Own CAPAs and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
• Time management skills are essential as investigators will be required to own and manage multiple investigations or CAPAs and adhere to assigned due dates and tight timelines.
• Ability to work independently is a must
• Ability to work and collaborate with staff from all departments is required.
• Knowledge of TrackWise or Master Control databases is preferred.
• Additional responsibilities may include cross-training as a Quality Contact to close investigations from other investigators and to close other reports in multiple quality systems.
• Participation in process improvements associated with investigation processes may be required.
• Other duties may be assigned
Supervisory Responsibilities:
Directly supervises three employees in the quality systems department.

Education and/or Experience:
Bachelor’s Degree in Science, Chemistry, or Biology.  Five (5) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry, OR ten (10) years of < in Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.  Must have knowledge of the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory.  Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedures.  Ability to effectively present information and respond to questions from groups of managers, and customers Mathematical Skills:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis Computer Skills:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Other Skills and Abilities

• Must have demonstrated ability to work independently and as a team leader.
• Able to organize and write complex technical documents.
• Ability to write clear, concise, complex reports, assessments and documents
• Excellent written and verbal communication skills
• Ability to facilitate multifunctional meetings
• Extensive knowledge of cGMP, EU and other country regulation ns involved in the technical development and manufacturing processes of pharmaceutical drug products.  Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, 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, Chapter 21, Part 11.
• Familiar with GUI (Graphic User Interface) such as Windows 98, 2000, XP and instrument manufacture based systems (Chemstation, Empower). Familiar with Microsoft Word and Excel computer programs.  Must also have extensive working knowledge of Documentum, Trackwise, Eduneering, JD Edwards and Batch Record Tracking.  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

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