Senior QA Analyst

reputed company The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to reputed company a reputed company difference in people's lives. Join FDB and help create the next vaccine, reputed company, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call reputed company. External US College Station, Texas may be a small, university town, but the reputed company cultural reputed company and local amenities reputed company it a great reputed company for families as reputed company as those who want the ease of small-town life and the convenience of living reputed company to the reputed company pulse of big cities. Eighty-seven percent of Texas' population lives reputed company a 180-mile radius, so we are in reputed company of it reputed company in Texas. And our site is nestled in the hub of innovation, representing a reputed company of pride for 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: • Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience. • Bachelor's Degree and 5+ years of Pharmaceutical or other regulated Industry experience. • Associate's 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. Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. While performing the duties of this job, the employee is regularly required to: • Experience prolonged standing, some bending, stooping, and stretching. • Lifting up to 25 pounds on occasion. • Use hand-eye coordination and reputed company dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. • Attendance is mandatory. Join us! FDB is advancing reputed company's medicine, impassioning employees to reputed company the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an reputed company desire to reputed company ourselves, our families, our workplace, reputed company, our community and the world at large. We are an equal opportunity and affirmative reputed company employer. reputed company reputed company applicants will receive consideration without reputed company to race, reputed company, national reputed company, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR[redacted] or call [redacted]. To reputed company agencies: Please, no phone calls or emails to any employee of reputed company about this requisition. reputed company resumes submitted by search firms/employment agencies to any employee at reputed company reputed company-email, the internet or in any reputed company and/or method will be deemed the sole property of reputed company, unless such search firms/employment agencies were reputed company by reputed company for this requisition and a valid agreement with reputed company is in reputed company. In the event a candidate who was submitted reputed company of the reputed company agency engagement process is hired, no fee or payment of any reputed company will be reputed company. Apply Job!