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Quality Analyst I
Ref No.: 18-09046
Location: Newbury Park (Thousand Oaks), California
Start Date / End Date: 08/21/2018 to 02/20/2019
Summary
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 Client 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.
Qualifications
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.
Working Environment
List the specific working environment that the employee will work in to perform his/her essential duties and responsibilities:
• 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.