Quality Assurance Specialist III

Job Description

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Quality Assurance Specialist III to work for a leading Greater Orange County area contract manufacturing company.

Pay Rate: $35-40/hour

Duration: 6+ months - possibility of conversion down the line, but not guaranteed

Responsibilities:

• QC testing pH, water content, assay titration, Loss on drying. UV. FTIR, HPLC, GC., mineral and microbiology  The candidate also familiar with USP. EP. JP compendial testing. 

• US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Develop and revise QA procedures to strengthen cGMP compliance.  

• Reviewing test results and supporting technical documentation. Work directly with operations management to resolve findings noted during the review process.  

• Performing release of raw materials and consumables.  

• Reviewing and approving Certificate of Analysis for raw materials, drug substance and drug products.  

• Collaborating effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications trend reports and other quality documentation.  

• Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.  

• Reviewing and approving deviations and gather/issue quality metrics reports to QA management.   

• Providing QA support during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies.   

• Acting as a co-auditor during supplier/internal quality audits  

• Providing subject matter expertise for the supplier assurance program at the site  

• Providing QA management with the support needed for compliance training.  

• Maintaining workspace cleanliness by adhering to the 5S method of organization.  

• Abiding by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.  

• This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.  

Experience/Requirements:

• Bachelor's degree with 3-5+ years in Lab & QA, or a minimum of 4+ years with both lab & QA related work experience. 
• Advance experience and knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to contract laboratory and/or aseptic manufacturing operations.  
• Advance experience and knowledge of USP, Pharm. Eur. (EudraLex) and other applicable standards.  
• Advance knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.  
• Advance experience and knowledge in the use of LIMS and electronic documentation systems.  
• Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.  
• Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.  
• Works on complex issues; exercises good judgement in selecting methods, techniques and evaluation criteria for obtaining results while handling Quality Assurance tasks.  
• Ability to perform routine work with minimal instructions, determines methods and procedures on new assignments.  
• May coordinate activities of other personnel.  
• Ability to work effectively under pressure in a rapidly changing environment.  
• Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.  
• Ability to seek critical information from key resources to assist in problem solving.  
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).  

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