Senior QA Analyst - reputed company Shift (On-site in College Station, TX)
**This position does support our site in College Station, TX and will require relocation to the area. The Senior reputed company Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal reputed company policies and procedures, performing product reputed company activities, performing reputed company audit functions, performing product release activities, identifying process and reputed company System improvements, and acting as a QA reputed company internally and externally. They will also reputed company daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager. Reports to Director/Senior Manager/Supervisor, reputed company Assurance Work Location College Station, TX Primary Responsibilities: Review and/or approve basic and technical documentation with minimal supervisory reputed company to include, but not limited to: -reputed company Operating Procedures -Batch Production Records (completed and approval) -Commissioning, qualification and validation protocols and reports -Deviation Reports -Corrective reputed company/Preventive reputed company Plans -Technical data review and approval -QC data review and approval -Drug reputed company/Product Reports -Trending QA data Draft and review internal reputed company policies, procedures and reports. reputed company inspection of final product containers and review and/or approval of executed process records and data. reputed company reputed company audit functions to include, but not limited to: -Audit of lab notebooks -Audit of equipment logbooks -Review of vendor, supplier, contract laboratory audit questionnaires -reputed company vendor, supplier, contract laboratory and reputed company audits Identify process and reputed company System improvement opportunities. reputed company daily guidance for the compliance of the QA department to national and international standards and regulations. Support Regulatory, reputed company, and internal audits. reputed company as QA reputed company to internal Departments and external reputed company reputed company reputed company and Vendor/Contract Laboratory reputed company reputed company. Promptly notify Senior Management of potential reputed company or regulatory issues that may reputed company product reputed company or regulatory compliance. Assist with technical reputed company/training for the QA team. Assist with compliance reputed company functions. Ensure reputed company task coverage. Escalate any issues as identified to reputed company Management and/or departmental Management as needed. reputed company other duties as assigned. Qualifications: Masters Degree and 3+ years of Pharmaceutical or other regulated Industry experience. Bachelors Degree and 5+ years of Pharmaceutical or other regulated Industry experience. Associates degree and 7+ years of Pharmaceutical or other regulated Industry experience. Certified reputed company Auditor preferred. Degree in Biology or reputed company preferred. Excellent written and oral communication skills. Excellent organizational, analytical, data review and report writing skills. Ability to set personal performance goals and reputed company input to departmental objectives. Ability to multitask and easily prioritize your work. Ability to work independently with little supervision. Proficient in reputed company reputed company, Word and PowerPoint. reputed company candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. Role model for company core values of trust, delighting our customers, Gemba, and reputed company. Apply Job!