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QC Associate II
6397 Kaiser Drive Fremont, CA 94555 US
Job Description
- Execute and coordinate routine and non-routine testing in Quality Control (QC) for bulk drug substances and drug products within a multi-product facility.
- Perform fundamental operations independently, such as biochemistry, drug product device testing, UV-Vis absorbance, gel electrophoresis, pH, and osmolality, following adequate training.
- Provide internal support including stocking consumables/materials, updating controlled SOP binders, discarding expired reagents, and recognizing/reporting process and equipment anomalies.
- Deliver high-quality analytical results within specified timelines and with accuracy ("right the first time").
- Document work in compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Adhere to established regulations and site-specific cGMP standards.
- Report abnormalities and deviations in a timely and accurate manner.
- Follow safety standards, identify unsafe situations or habits, and escalate as necessary.
- Maintain work production areas according to predefined standards (5S).
- Maintain compliance with training requirements and train other technicians and associates on operations upon completion of trainer qualification.
- Represent QC operations on cross-functional root cause analysis teams for deviations, Corrective and Preventive Actions (CAPAs), and risk assessments.
- 3-5 years of industry experience.
- GMP experience is highly preferred.
- Strong interpersonal and communication skills (both written and oral).
- Demonstrated customer focus and ability to interact with various departments and levels.
- Ability to work independently and as part of a team to meet departmental and facility goals.
- Capable of working across functions to achieve common objectives.
- Strong attention to detail and focus on the execution of tasks.
- Bachelor’s degree in Biology or Life Sciences required.
Pay Rate Range: $20-34/hr. Salary will be commensurate with experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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