One of the world's leading companies in the fields of health and nutrition, delivering breakthrough innovations in healthcare and agriculture. Contribute to a world in which diseases are not only treated but effectively prevented or cured, in which people can take better care of their own health needs, Join this team which is Guided by the purpose "Science for a better life"
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: Berkeley, California
job type: Contract
salary: $35 - 50 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Description:
Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records).
Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management.
Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.
qualifications:
Skills & Qualifications (education, experience):
- Bachelor's degree in a scientific/ technical field.
- Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations.
- A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
- Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process.
- Previous work in Quality Assurance (e.g., release) preferred.
- Proven ability as a team player and leader.
- Excellent interpersonal skills
- Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
- Ability to work both independently and team environment.
- The ability to multitask and support changing priorities
- Strong written and oral communication skills
- Ability to assess, investigate and resolve deviations.
- Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
- In depth knowledge of GMP
skills: Quality Assurance, 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.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
