Quality Assurance Specialist Quality Assurance Manager - Biotech Res
Quality Assurance Specialist   Quality Assurance Manager - Biotech Res
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Quality Assurance Specialist / Quality Assurance Manager Resume

Desired Industry: Biotech SpiderID: 81035
Desired Job Location: Danville, California Date Posted: 5/31/2018
Type of Position: Full-Time Permanent Availability Date:
Desired Wage: 120000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: No

Methodical, results-driven, and performance-focused professional, offering progressive experience in quality assurance and control. Hands-on leader; expert at developing and implementing cost-effective strategies; maintaining and ensuring quality; and utilizing manufacturing technologies and processes toward operational efficiency and productivity. Adept at adhering to Code of Federal Regulations (CFR), Food and Drug Administration (FDA), and ICH regulations regarding drug development and manufacturing. Effective at building strong relationships and working collaboratively with various teams, associates, and other professionals.

Areas of Expertise

Program and Operations Management ~ Regulatory and Standard Compliance ~ Reports Analysis and Inspection
External and Internal Audit ~ Production Planning and Control ~ Manufacturing Equipment Maintenance
Staff Supervision and Training ~ Continuous Process Improvement

Relevant Experience

Amneal Pharmaceuticals, Inc. (formerly Impax Laboratories Inc.) • Hayward, CA
Quality Assurance (QA) Supervisor Mar 2013–Present
Directly supervise QA associates while efficiently managing all internal and external research and development (R&D) activities at contract manufacturing organizations (CMO) and contract packaging organizations (CPO)
Actively collaborate with R&D Core Management Team to ensure alignment with project timelines and efficient abbreviated new drug approval (ANDA)/new drug approval (NDA) submissions
Conduct assessment and approval of standard operating procedures (SOPs); master batch records; investigations into manufacturing deviations; and specifications for drug substances, packaging materials, and finished products
Render hands-on assistance with Food and Drug Administration (FDA) audits

Research and Development QA Associate II Jun 2009–Mar 2013
Fulfilled various QA manufacturing support activities involving in-process testing, good manufacturing practice (GMP) audits, acceptable quality limit (AQL) inspection, and rooms and equipment release
Executed thorough analysis and approval of batch and test records and other documents for drug substance and final drug product release
Facilitated evaluation of quality control data regarding product release and stability activities as well as analytical methods, validation protocols, and reports
Served as key point of contact for all deviation investigations, including tracking and trending
Rendered keen oversight to corrective action preventive action (CAPA) program
Exemplified outstanding performance, thus receiving promotion from QA associate II to QA supervisor responsible for the R&D teams and QA associates

Research and Development QA Associate I Nov 2007–Jun 2009
Offered support on daily manufacturing floor operations, which involved gathering in-process samples, performing in-process audits, releasing manufacturing equipment and rooms, and facilitating other GMP support activities
Held full accountability in analyzing manufacturing batch records and other GMP-related documents such as study protocols and standard operating procedures
Earned promotion from QA associate I to QA associate II due to exemplary dedication and performance in delivering robust quality system

Other Experience

United Parcel Service • Oakland, CA
Supervisor May 2002–Mar 2006


Bachelor of Science in Biology – California State University, East Bay, Hayward, CA


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