Shire Compliance Investigator III - Supervisor in Los Angeles, California
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.
Train and develop Lead Quality Technicians to support department goals.
Hire, train, review and evaluate personnel. Perform mid-year and yearly performance reviews of all direct reports and makes wage and salary recommendations. Organize meaningful team building events.
Ensure that corrective actions and Improvements are implemented per committed timelines.
Conduct Investigative sampling of the manufacturing areas as appropriate. This requires qualification on general sampling techniques (e.g. Swab sampling) and basic testing methodologies.
Lead and/or 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 (such as CAPA 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.
Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to OOL/OOS Investigations.
Maintain training on general laboratory procedures to enable adequate review of test data, including overall GDP.
Develop Investigative sampling plans and/or experiments for root cause analysis of laboratory 1est techniques or rapid Identification of microbial contamination sources.
Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, GLP. CSR and cGMP regulations investigate deviations and write exception documents.
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. Capable of developing strategies and drive right first time and event reduction goals.
Prepare and present root cause and/or trend analyses to management during routine operating mechanisms (e.g. Management Review and CAPA Review Board).
Generate, review, and make complex revisions to procedures and laboratory documents.
Required to present investigations during internal and external regulatory inspections.
Drive lean principles such as 5S throughout daily work activities.
Ensure personal training requirements are met and that training records are current.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Strong organizational skills and ability to plan and suggest resolution to technical problems.
Strong understanding of critical manufacturing and facility processes/equipment.
Understand scientific strategies and be able to invent new processes or new avenues of Investigation.
Clean room or laboratory experience and knowledgeable In aseptic techniques.
Must be detail oriented, conscientious and have a high reading comprehension skill. Capable of effectively communicate and Interpret data.
Computer literate and competent with a working knowledge of work processing and spreadsheets (such as Microsoft Office). Capable of performing advanced trending.
Strong Interpersonal communication and influencing/negotiation skills. Must have strong verbal and written communication skills. Evidence of general presentation skills required, good presentation skills are a plus.
Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
Demonstrates the ability to lead and motivate people, encourage team work, teach investigational techniques, and assist Manager in driving team objectives.
Must be able to effectively manage employees, conduct performance reviews, establish development plans, and manage resources.
Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
Demonstration of strong project management skills, strong leadership, organization, and time management skills.
Must be able to learn new computer systems and programs in a timely manner.
Demonstrate good knowledge of Quality system.
Education and/or experience
Typically requires bachelor’s degree in chemistry, biological science, or other related technical field.
5+ years of related experience.
Some leadership experience preferred.
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.