WuXi AppTec · 8 hours ago
Quality Assurance Specialist
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$68K/yr - $89K/yr
5+ years expWuXi AppTec is a company focused on pharmaceutical services, and they are seeking a Quality Assurance Specialist. The role involves reviewing and approving analytical data, maintaining compliance documentation, and collaborating with cross-functional teams to ensure quality standards are met.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Supports QA review, approval, and disposition of analytical data for raw materials, starting materials, intermediates, and API release
Reviews and approves qualification protocols and reports for equipment
Reviews and approves protocols and reports for analytical methods
Coordinates Change Control activities associated with validations and commissioning of new equipment
Reviews and approves production batch records
Reviews and approves equipment cleaning records
Performs manufacturing line clearance
Release of equipment and rooms for production
Authors, revise, review and implement Standard Operating Procedures (SOP), TWI, FOR, REG
Reviews and approves quality documents such as deviations, CAPAs, out of specifications (OOX), out of calibrations, and amendments
Leads investigations, deviations, and corrective actions to ensure compliance and completion within a specific period
Maintains GMP documentation for accuracy, completeness, and compliance to established standards
Maintains inspection ready procedures and participate in internal/external audits
Participates in opportunities to develop knowledge of cGMP and business operations
Collaborate with other functional groups and perform other duties and responsibilities as needed
Coordinate and review Environmental Monitoring (EM)
Review calibration certificates from Operations and QC
Keep the QMS well organized in the document control rooms and shared drives
Communicate with clients when needed
Vendor qualification
Assist with the training program
Provide support during audits
Qualification
Required
5 years or more of relevant experience working in the pharmaceutical industry
Requires thorough knowledge of cGMPs, ICH, and relevant FDA guidelines
Ability to manage multiple assignments and changing priorities
Demonstrated understanding of cGMP manufacturing for biopharmaceutical products
Strong organizational skills, knowledge of interpretation of analytical data, instrumentation, and electronic data review with emphasis on Empower 3
Efficient in addressing deviations, investigations and corrective actions to ensure compliance and completion within a reasonable period
Ability to work under pressure
Proficient in Microsoft (Excel, Word, Outlook)
Must be able to work in an office environment with minimal noise conditions
Must be able to work in an environment with variable noise levels
Ability to stand/sit/walk for extended periods of time
Ability to crouch, bend, twist, and reach
Clarity of Vision
Ability to identify and distinguish colors
Preferred
Minimum BS in chemistry/biology or related scientific discipline preferred
CDMO experience is beneficial
Experience in supporting early phases of API development
Company
WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical.
10001+ employees
H1B Sponsorship
WuXi AppTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (1)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.59BKey Investors
Eight Roads Ventures
2025-03-03Acquired
2018-05-08IPO
2016-03-06Debt Financing· $1.5B
Leadership Team
Ge Li
CEO
Recent News
South China Morning Post
2026-01-23
Morningstar.com
2026-01-19
2026-01-15
Company data provided by crunchbase