Job Title: QC Associate II Location: Fremont, CA 94555 Duration: 7+ Months 1st Shift: Monday-Friday: 9AM to 6PM Some overtime and weekends may be required as needed.
Details:
Executes and coordinates routine and non routine testing in QC of bulk drug substance and drug product in a multi-product facility.
Executes independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty
Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Delivery of high quality analytical results within timeline right the first time Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner.
Adheres to safety standards and identifies unsafe situations / habits and escalates approriately. Maintains work production areas according to predefined standards (5s).
Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments.
Skills:
3-5 years of industry expereince
GMP experience is highly prefered
Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of execution
Education: Bachelors' degree in Biology or Life Sciences required
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $33.24/hr.