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myGwork - LGBTQ+ Business Community · 3 days ago
QA Engineer II
San Francisco, CA
Full-time
Onsite
Entry, Mid Level
$72K/yr - $108K/yr
2+ years exp
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Responsibilities
Collaborate across functions, demonstrating quality and manufacturing expertise to address problems, interpret data, and determine next steps.
Support implementation of secondary suppliers and assist with the development of raw material specifications.
Participate in change control activities for documents and manufacturing processes.
Ensure accurate use of quality systems and processes.
Provide mentorship and direction to ensure ISO/Quality system compliance.
Spearhead maintenance, completeness, and accuracy of Quality records.
Lead problem requests (nonconformance's), complaint records, and corrective and preventive actions (CAPAs).
Build, review, and revise quality policies and procedures, and perform trainings when needed.
Review batch records in accordance with cGMP, including good documentation practices (GDP).
Ensure traceability to materials and equipment.
Generate Certificate of Analysis for finished good materials.
Identify and record any deviations related to a product's release; help process, and review deviations as needed.
Complete product release steps in our business systems.
Supports internal and external audits, including audit of batch records and release activities for cell therapy products.
Write, review, and revise Standard Operating Procedures (SOPs).
Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners.
Support Vendor Qualifications. Identify and implement improvements using quality data, metrics, and Practical Process Improvement (PPI) tools.
Qualification
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Required
Bachelor's degree in science or engineering, or related field is preferred. Equivalent education and experience can be substituted.
2+ years of relevant Quality/Manufacturing/Engineering or related experience.
Previous experience in a cGMP environment.
Previous experience in Cell Therapy is preferred.
Proven track record to collaborate in multi-functional teams.
Demonstrated ability to conduct quality investigations including root cause analysis.
Strong verbal and written communication skills in English.
Solid understanding of cGMP practices.
Knowledge of regulatory guidelines: EU, US, ICH, etc.
Change control, Deviation and investigations, root cause analysis and risk assessment.
Preferred
Experience With SAP, TrackWise, LIMS, EDMS Is Preferred.
Effective written, interpersonal, and presentation skills.
Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and ability to learn new software programs.
Benefits
Healthcare
Company Pension/Retirement
Employee Assistance Programs
Commuter Benefits
Tuition Reimbursement
Paid Time Off
Paid Holidays
Paid Parental Leave
Life Insurance
Short- and Long-Term Disability
401(k) U.S. Retirement Savings Plan
Employees' Stock Purchase Plan (ESPP)
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Leadership Team
Adrien Gaubert
Co-Founder & CMO
Recent News
2024-04-10
Company data provided by crunchbase
