Perform root cause analysis for Microbiology or Biochemistry, non- conformances (OOL, OOS, and CAPA). Responsible for timely documentation of comprehensive Investigations related to environmental monitoring, personnel monitoring, critical systems monitoring, in-process product monitoring, final container testing, and stability testing. Work closely with the corresponding manufacturing, quality assurance, or critical systems personnel to investigate suspect results. Win lead Investigation teams and drive root cause identification with team setting. May be involved with leading teams, encouraging teamwork, problem-solving and making sound (e.g. technical, compliance, and operations) assigned decisions. Analyze bioburden data and prepare presentations for management. Participate and/or drive completion of improvement projects. Essential Duties and Responsibilities
- Conduct thorough scientific, defensible Investigations for any OPOL, CAPA, or OOS excursion.
- Conduct and document Investigation In a timely manner to support the on-time closure of on conformances to meet product fulfillment dates.
- Conduct Investigative sampling pf the manufacturing areas as appropriate. This requires qualification on general sampling techniques (e.g. swab sampling) and basic testing methodologies.
- Support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams. Will lead routine Investigations and may be required to lead complex investigations.
- Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and drive closure of non-conformances In accordance with cGMP and quality systems.
- Mentor other QA position. Train staff and assure training requirements are met and re cords are current.
- Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to OOUCAPA/OOS Investigations.
- Maintain training on general laboratory procedures to enable adequate review of test data, including overall GDP.
- Assist In developing Investigative sampling plans and/or experiments for root cause analysis of laboratory test techniques or rapid Identification of microbial contamination sources.
- Lead and/or actively contribute to a team setting within the Laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents, when assigned.
- Participate In Lean principles such as 5S throughout dally work activities
- Ensure personal training requirements are met and that training records are current.
- Lead or support Right First Time Initiatives.
- May be required to present investigations In Inspections, along with Management.
- Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).
Education and/or experience
- Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
- Effective organizational skills and ability to plan and suggest resolutions to technical or resource problems.
- Good organizational skills and ability to plan and suggest resolutions to technical problems.
- Proficient with lab application software and able to learn new computer systems and programs in a timely manner.
- Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
- Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
- Must be detail oriented, conscientious and have a high reading comprehension skill.
- Good understanding or critical manufacturing and facility processes.
- Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills. Effective presentation skills a plus.
- Understand scientific strategies and be able to invent new processes or new avenues of investigation.
- Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
- Must be able to learn new computer systems and programs in a timely manner.
- Demonstrate good process, critical system understanding and lead investigations to provide comprehensive investigation write up.
- Capable of navigating through Quality systems and has working knowledge of event management system.
- Master's Degree in a Scientific or Engineering discipline with 1+ years of relative experience
- BS degree in a Scientific or Engineering discipline with 2+ years of relative experience.
- Must be able to lift, push, pull and carry up to 25 lbs
- No contact lenses may be worn in the work environment. No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility
- May be required to enter a cold, wet environment and climb stairs or ladders to retrieve samples.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required (APPLICABLE TO SNE only).
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.