Search Jobs
Quality Assurance Specialist IV
7555 Gateway Boulevard Newark, CA 94560 US
Job Description
JOB SUMMARY:
The Specialist IV provides compliance support or oversight for operational functions. This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control).
- Conducts investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis.
- Monitors completion of the quality system records and provides escalation to management, as needed.
- Generates and analyzes metrics for operational activities, including but not limited to laboratory investigations and invalid assays and other laboratory operation parameters as appropriate.
- Authors and/or revises other controlled documents such as procedures, methods, work instructions, protocols, and reports as applicable.
- Ensures personnel compliance of corresponding training programs for supported operational functions.
- Provide technical writing in support of operational functions, such as Quality Control (QC).
- Responsible for authoring Out of Specification (OOS) and anomalous event laboratory investigations, deviations, CAPA, and change controls.
- Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and/or conducting investigations.
- Conduct investigations thoroughly for OOS events according to the phase-based approach per FDA and Annex guidelines.
- Investigate deviations to identify root cause and contributing factors and in parallel assess impact to patients, product quality, data integrity, validated state, and regulatory compliance.
- Identify and develop relevant and effective CAPA.
- Address impact to systems, processes, product, and any regulatory requirements when authoring change controls.
- Prioritize and monitor completion of lab investigations, deviations, CAPA, and change controls.
- Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines.
- Generate and analyze metrics as applicable.
- Manage and author change controls related to qualification, modification, and/or decommissioning of equipment.
- Possess a strong understanding of data integrity principles.
- Ensure compliance of personnel with corresponding training program(s).
WORK ENVIRONMENT and PHSYICAL DEMANDS:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 10 pounds at times.
EXPERIENCE:
- A minimum of 3 years work experience within a GMP environment working with small and/or large molecules.
- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC (Waters Empower software is preferred), and Relative Potency Assay.
- Solid technical training and troubleshooting experience are essential.
- Strong understanding of data integrity principles within a GMP environment is required.
PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER):
- Expertise in use of Microsoft Office applications.
Education:
- Bachelor's in biology, biochemistry or related pharmaceutical-biotechnology discipline is required.
Pay Rate Range: $45-65/hr depending on 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.
Share This Job:
Related Jobs:
About Newark, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.