This role is responsible for performing the day-to-day quality operations. You will identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines, and Takeda quality practices.
Schedule/Shift: 1st shift, Mon.-Fri., 8am-4:30pm
Position Type: Contract position for 6 mos. with potential for extension.
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Newbury Park, California
job type: Contract
salary: $25.00 - 29.08 per hour
work hours: 8 to 4
education: High School
- Review pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance based on regulatory requirements and internal guidelines, etc.
- Identify areas of nonconformance and escalate to management (Manufacturing and Quality) for initiation of a Deviation.
- Conduct, perform, and/or review investigations for non-conformances within respective area. Assist in identifying corrective actions to prevent recurring non-conformances.
- Administer and maintain relevant databases, prepare, and issue reports defined by the area, and develop custom reports as needed.
- Assist in external and internal audits/inspections by maintaining audit records, extracting data from databases, and creating reports, collecting relevant data, etc.
- Support process with timely closure of observations/audit items.
- Serve as a team member and/or assist in CAPA Investigations for significant issues within respective area.
- Maintain and update departmental business indicators.
- Prepare metrics for the Management Review of Quality Systems.
- Audit/review documents as needed for completeness, CGMP's, company procedures and verification of data. Correct any deficiencies found.
- Assist and/or prepare Annual Product Review (APR) for products as directed.
- Write Technical reports (e.g., PQR and YBPR)
- Assist in the development, review, and revision of SOPs in support of Division Procedure Compliance and continuous improvement efforts as needed.
- Assist in training Quality team members
- May perform other duties as assigned
- High school diploma or equivalent required .
- Bachelor's degree (BS) in a scientific discipline preferred .
- Three (3) to five (5) years of related work experience.
- The overall physical exertion of this position is sedentary.
- May require lifting and carrying of up to 10 lbs.
- Batch record Review on the Floor (BRR) may require being on your feet for long periods of time.
- Strong interpersonal skills and great attention to detail are necessary.
- Strong team player with effective communication skills and able to handle multiple projects concurrently
- Able to apply problem solving tools and methods to coordinate and/or lead investigation teams.
- Good understanding of Current Good Manufacturing Practices (CGMP) as well as Good Documentation Practices (GDP).
- Knowledge of FDA regulations, Application of Good Laboratory Practices and Application of Good Manufacturing Practices
- Experience with Microsoft Excel, Word, and PowerPoint
- Normal office environment.
- Able 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, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
- May work in a cold, wet environment or cool/hot storage conditions; may be exposed to sunlight, heat, dust, gases and fumes
- May climb up and into large processing tanks for cleaning or inspection.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
- May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
- May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- May require immunization before performing work within the manufacturing area.
- May require overtime, weekend, and holiday work.
- May be assigned to a different shift as needed.
skills: FDA, Quality Assurance, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.