This Technical Specialist role is a remote, one-year contract focused on managing and implementing raw material specifications for both clinical and commercial manufacturing. You will bridge the gap between technical attributes and quality compliance by drafting specifications for biologics and small molecules while acting as a key initiator within the Change Control Management System (CCMS). The position requires a proactive facilitator who can lead cross-functional meetings with Process Development and Supply Chain teams to ensure all material controls are documented and executed with precision.
location: Telecommute
job type: Contract
salary: $40.00 - 45.99 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
- Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). Interface cross-functionally within Company (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Company raw material suppliers.
- Draft specifications based on raw material attributes, where they are used in the Company process and how they should be controlled.
- Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
- Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
qualifications:
- Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.
- Draft specifications based on raw material attributes
- Facilitate specification development meetings and generate meeting minutes/action items
- Change owner and initiator
skills: Chemistry, Good Manufacturing Practices (GMP), Process Validation, Change Control Management, Quality Assurance (QA), Clinical Supply Chain Risk Mitigation, Raw Materials
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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 with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
