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Quality Assurance Specialist II

Newark, CA 94560

Posted: 06/10/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607667 Is job remote?: No Country: United States

Job Description


JOB SUMMARY:
We are a commercial stage biotechnology company focused on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcare. The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program and incoming attribute inspections. The individual will also assist in quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will be interacting with cross-functional groups such as Quality Control, Manufacturing and Regulatory Affairs.

ESSENTIAL DUTIES:

• Perform a wide variety of quality assurance activities to ensure compliance with company procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.
• Manage the reserve sample program.
• Perform incoming quality attribute inspections.
• Coordinate and track closure of the change controls, deviations, quality investigations and CAPAs.
• Prepare quality system metrics.
• Review and disposition of incoming raw materials.
• May support quality operations, as needed (e.g., review executed records such as batch records/ quality control data or equipment qualifications; perform line clearance and product inspection; review other records under supervision such as change control requests, deviations, lab investigations, environmental monitoring excursions, proposed CAPAs).
• Support continuous improvement of quality systems. Author new, revise existing department procedures and/or forms.
• Assist in internal compliance audits as needed.
• Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
• Other duties as assigned.

EXPERIENCE:

• Minimum 4 year’s experience performing quality functions in pharmaceutical and/or biotech related fields.
• Some working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP.
• Works under moderate supervision.
• Ability to independently analyze and reconcile simple issues.
• Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.
• Good verbal and written communication and interpersonal skills.

PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER):
• Proficient with commonly used word processing, database systems and other software.
Education:  

• BA or equivalent in biology, chemistry or related science or equivalent experience.

WORK ENVIRONMENT and PHSYICAL DEMANDS:
This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 10 pounds at times.


We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. We do not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.








Pay Rate Range: $30-45/hr. Salary will be commensurate with experience 
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About Newark, CA

Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.