Shire Sr QA Inspector in Thousand Oaks, California
This position reports to Shift 2 (Swing Shift) working 4 - 10 hour days per week. The schedule is every Monday, Tuesday, Friday and Saturday from 10:00 AM to 8:00 PM.
Responsible for performing the day-to-day quality operations (QA Inspection) for QA Filling/Finishing within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines and Shire quality practices.
Essential Duties & Responsibilities
Responsible for QA Inspection activities associated with Aseptic Filling, Capping, Packaging and Label Management.
Conduct JD Edwards (JDE) transactions for inventory management, as well as, product status updates.
Support product complaint investigations.
Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc. Support process with timely closure of observations/ audit items.
Revise or review standard operating procedures (SOP’s).
Participate in process improvement projects.
Responsible for batch record review. Ensure that all steps have been documented and verified. Ensure processes are performed within applicable limits relating to departmental SOP’s. Ensure that all appropriate testing meets specifications.
May perform other duties as assigned.
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and Application of Good Manufacturing Practices.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must have uncompromising dedication to quality.
Must have relentless focus on rapid and disciplined action.
Must have respect for individuals and the diverse contributions of all.
Passion for Improving Lives. Must be able to put our patients at the center of everything we do.
Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
Inspired Teams environment. Must be able to thrive in diverse high performing teams.
Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Education and/or Experience
Associate degree in a scientific discipline and one to three years of relevant experience within most recent 5 years or an equivalent combination of education and experience.
Bachelor's degree in the life sciences, business or other technical field preferred. Experience in biotech industry within Filling/Finishing areas desirable.
Must be able to work a 4/10 day which may include a split shift schedule. One weekend day would be required.
Overtime may include weekends and holidays.
Must be able to work in controlled clean room environment requiring special gowning. Requirements include: no jewelry or cosmetics. Special gowning requires complete coverage of head, face, hands, feet and body. Personal protective equipment must be worn due to safety requirements.
Possible exposure to cold/hot storage conditions.
May be exposed to dust, gases, and fumes.
May be around moving equipment and machinery (e.g. forklifts, pallet jack).
May be required to work or be assigned to a different shift as needed.
May be working in a loud area that requires hearing protection and other protective equipment to be worn.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
Physical Demand Level - MEDIUM.
Rarely Lifting - Up to 50 pounds.
Frequent Lifting - 15 - 35 pounds.
Standing - Frequent - Function performed as employee supervises and assists in manufacturing areas.
Total standing and walking can be up to 7 + hours in a 10 - hour workday.
Walking - Frequent.
Sitting - Frequent - Production of reports.
Pushing/Pulling - Required in some positions to inspect equipment, access alternative areas of facility, move labeling carts.
Overhead reaching - Occasional- to obtain and place materials for inspection or reach needed materials.
Squatting - Occasional - To observe materials and equipment at floor level. Crawling - Rarely.
Hand/Finger Feel - Frequent - Employees are required to handle the individual packages and handle small fine parts. Parts will have multitudes of textures and sizing.
Gripping/Grasping - Frequent - Employees are required to use hand tools and possible other equipment to assist in the manufacturing and quality assurance of products.
Drive - Rarely - as to non-commercial motor vehicles.
Communication - Constant - Employees must be able to communicate orally and in writing in a clear, concise undersandable manner to supervisor and instruct co-employees. Including use of computer, telephone and related communication instruments.
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, gender identity, 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.