Job Description
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values :
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Quality Validation Specialist Responsibilities :
Responsible for quality oversight of validation activities at the Takeda Los Angeles facility. This person will have quality signatory responsibility for approval of qualification, validation, and final report documents. Ensure that the validation and compliance requirements are met according to guidelines and Takeda standard operating procedures. Proficient in facility quality systems and participates as subject matter expert of validation requirements. The scope includes validation for Facility, Equipment, Critical Utility, Automation Systems, Cleaning and Process.
Essential Duties and Responsibilities :
Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performedProvide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirementsReview from a quality perspective, the validation approach and documentation as required to assure compliance with procedures and regulatory submissionsReview from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissionsParticipate in the risk assessment related to the projectAssure requirements traceability throughout the whole project life cycleEvaluate, analyze, and approve protocol discrepancies and ensure that the required corrective actions are takenMay perform other duties as assignedRequirements :
Strong interpersonal skills and great attention to detail are necessaryMust be a strong team player with good problem solving, and good verbal and written communication skillsMust be able to handle multiple projects concurrently, have computer experience and have extensive knowledge of FDA Regulations and GxPsMust have experience in pharmaceutical / biotech validation which includes the writing and executing of protocolsMust have experience or advanced training and demonstrate proficiency (e.g. Takeda's quality systems such as validation, change control, etc., statistical methods / six sigma training, problem analysis and resolution, design of experiments and process development / pilot scale work)The individual will have proficiency in plasma fractionation and purification processesSuccessful track record of analyzing complex technical problemsDemonstrates good troubleshooting and decision-making abilitiesMust be self-motivating and able to handle multiple projects / systems concurrentlyAbility to design and influence in own area of expertiseExtensive cross-functional team experience, including technical and non-technical workMust have the following personal attributes : integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and convictionMust have passion to innovate and drive for solutionsMust display personal accountability for results and integrityMust have uncompromising dedication to qualityMust have relentless focus on rapid and disciplined actionMust have respect for individuals and the diverse contributions of allTypically requires BA or BS degree preferably in the engineering or science field. 5 years of related experienceMust be able to lift, push, pull and carry up to 25 lbsIn general, the position requires a combination of sedentary work and walking around observing conditions in the facilityMust 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 bodyNo make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environmentWill work in a cold and / or wet environmentMust be able to work multiple shifts, including weekendsMay be required to work in a confined area.For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
Verista is an equal opportunity employer.National (US) Range
70,491—$142,808 USD
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Salary : $70,491 - $142,808
