Quality Analyst II
Thousand Oaks, California
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Quality Analyst IIApply Now
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
“Every vial has a name” is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Quality Analyst II. The selected candidate is responsible for performing the day-to-day quality operations for Quality Lab Services within the Quality organization. He/she will be responsible for initiating and driving change control, initiating and investigating deviations, coordinating external lab testing, and participating in quality process improvements for the QC labs. The selected candidate will also be responsible for providing support for quality systems-related items. Will work with minimal supervision. The schedule is 1st shift split , Monday, Tuesday, Thursday, Friday from 7:00 am to 5:30 pm.
Responsible for performing the day-to-day quality operations for Quality Lab Services within the Quality organization. This position will be responsible for initiating and driving change control, initiating and investigating deviations, coordinating external lab testing, and participating in quality process improvements for the QC labs. Will also be responsible for providing support for quality systems-related items. Will work with minimal supervision.
- Lead change control activities, including change initiation, following up on assessments and tasks, leading cross-functional meetings as needed to ensure roadblocks are identified and resolved and that changes are on track to meet their target implementation/closure dates. Initiate, conduct, and perform investigations related to deviations and sample discrepancy reports. Serve as a team member and/or assist in investigations for significant issues within respective area.
- Prepare annual Product Quality Review (PQR) and Yearly Biologic Product Report (YBPR) for products as directed.
- Coordinate external lab testing such as post-production (mycoplasma, in-vitro viral, and MMV), general safety and pyrogen, Hepatitis B Surface Ag, calculated values for Rixubis and Vonvendi, and particulate matters. Process results from external labs on a timely manner to ensure no/minimal impact to product release.
- Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems
- 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.
- Administer and maintain relevant databases and files for tracking the status of change control and external lab testing.
- Identify and participate in process improvements within respective area.
- Write, revise, and/or review Standard Operating Procedures (SOPs) for accuracy and alignment to global procedures based on regulatory requirements and internal guidelines, etc.
- May perform other duties as assigned.
Education and Experience Requirements
Bachelor’s Degree in Chemistry or Biological Sciences. At a minimum, three (3) to five (5) years of experience in quality operations and/or equivalent years in biotechnology, pharmaceutical, or a similar GMP manufacturing environment required.
Key Skills, Abilities, and Competencies
- Knowledge of laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
- Knowledge of FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices and Application of Good Documentation Practices.
- In-depth understanding of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
- In-depth knowledge of quality systems including deviation management, change control, document control, etc.
- Ability to write detailed investigations that consistently meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies, implement investigation strategies, and apply root cause failure analysis.
- Strong team player with good problem solving skills.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must be able to handle/prioritize multiple projects concurrently and meet established deadlines and changing priorities.
- Must have good computer skills and be able to navigate electronic mail systems and the intranet for communication purposes. Must be proficient in LIMS, MS Office suite (including Word, Excel, PowerPoint, and Visio), Adobe, NWA, Trackwise, JD Edwards, COUPA, Saba, and Veeva.
- Must be proficient in a variety of mathematical disciplines and must be knowledgeable in using statistical tools such as Change Point Analysis.
- Strong verbal and written communication skills. Must be able to read, write, and converse in English.
- Must be very detail oriented and able to produce high quality of work.
- Must have the ability to complete tasks with minimal direction from supervisor and/or manager.
- Decision-making skills, technical problem solving ability, and analytical skills a plus.
- Documented/certified training in DMAIC and LEAN concepts preferred.
- Must have and display the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, courage and conviction.
- Must demonstrate the following Values: Must have a passion to
- prioritize the well-being of our team members and patients above all else
- serve our patients and keep them at the center of all we do
- treat each other as we wish to be treated, regardless of role or situation
- provide constructive feedback, raise the issue, make the change, and take accountability
- seek, adapt, and drive change, and working as a team is required for individual success.
Complexity and Problem Solving
- Must be able to escalate and communicate in a timely manner during ambiguous situations.
- Must be able to take ownership and resolve issues related to change control and deviations they own.
Internal and External Contacts
- Will coordinate regularly with external sites such as:
- Contract lab: OFI for Particulate Matter testing
- Contract lab: NAMSA for General Safety and Pyrogen testing
- Contract lab: Bioreliance for Mycoplasma testing
- External lab: Takeda, Vienna - Global Pathogen Safety for viral testing
- External lab: Takeda, Orth for MMV testing
- External lab: Takeda, Lessines for Hepatitis B Surface Ag testing
- Will coordinate as needed with Global Logistics
- Will coordinate as needed with DHL, World Courier, and Conejo Courier
Other Job Requirements
- Inside working conditions.
- May be exposed to sunlight and heat.
- Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room 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, jewery, contact lenses, nail polish, or artificial fingernails may be worn in these work environments.
- May work around chemicals such as alcohol, acids, buffers and other hazardous or biohazardous materials that may require special protection. May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
- May work around Methotrexate, which is a known cell growth inhibitor.
- May require immunization before performing work within the manufacturing area.
- May be around moving equipment and machinery.
- Possible exposure to cool/hot storage conditions.
- May work in a cold, wet environment.
- May be exposed to dust, gases, and fumes.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- May be required to travel for business reasons, e.g. training and meetings.
- Must be able to work more than 8 hours a day or 40 hours a workweek as required.
- Overtime may be required at times.
- Will be required to work an alternate work schedule (10 hour shift / 4 days a week).
- May be required to work or be assigned to a different shift as needed.
- Maybe required to work weekends and holidays.
The overall physical exertion of this position is light work:
- May be required to sit between 3-4 hours in all areas.
- May be required to walk between 3-4 hours in all areas.
- May be required to stand over 4 hours in all areas.
- May be required to bend at the neck over 4 hours in all areas.
- May be required to bend at the waist between 1-2 hours in all areas.
- May be required to squat between 1-2 hours in all areas.
- May be required to climb (use step stools and ladders).
- May be required to reach above/below the shoulder.
- May be required to twist at the neck/waist between 3-4 hours in all areas.
- May be required to lift up to 25lbs. Will be required to lift between 5-10lbs up to 10x per shift and 11-25lbs up to 1x per shift.
- May be required to carry up to 25lbs. Carry distance of between 5-10lbs up to 2-3ft up to 10x per shift and 11-25lbs up to 2ft up to 1x per shift.
- Requires use of both right and left hands and arms in all areas.
- Requires repetitive use of both right and left hands over 4 hours in all areas.
- May require simple grasping between 3-4 hours in all areas.
- May require power grasping of dominant hand/arm up to 1hr in all areas.
- May require fine manipulation over 4 hours in all areas.
- May require pushing/pulling with hands/arms between 1-2 hours in all areas.
- May require office work activities with hands/arms between 3-4 hours in all areas.
- May be required to gown frequently and balance when gowning into clean areas.
- May be required to drive cars, trucks, forklifts or other equipment.
- May be required to work around moving equipment and machinery.
- May be exposed to noise above 85 dBA in all areas. May require hearing protection and other protective equipment to be worn.
- May be exposed to hot, cold, wet environment/conditions.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
- May be required to work at heights above floor level.
- May require the use of special visual or auditory protective equipment.
- May be required to work with biohazards such as: bloodborne pathogens, sewage or medical waste in all areas. Includes Bioburden such as bacteria, molds and spores from environmental monitoring.
- May be required to drive to travel to other facilities, training sites, and off site meetings.
- May be required to work in confined areas.
- Will not be required to walk on uneven ground or slippery surfaces.
- Will not be required to kneel.
- Will not be required to operate foot controls or repetitive foot movement.
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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.
Job ID SR0043875