Senior Quality Assurance Analyst - Night Shift for Regulated Pharmaceutical Industry - Remote with Relocation to College Station, TX

Unlock Your Career Potential as a Senior QA Analyst at Workwarp Are you a seasoned Quality Assurance professional looking for a challenging and rewarding role in a dynamic and growing company? Do you have a passion for ensuring the highest quality standards in the pharmaceutical industry? If so, we have an exciting opportunity for you to join our team at Workwarp as a Senior QA Analyst - Night Shift. About Workwarp and the Pharmaceutical Industry Workwarp is a leading company in the pharmaceutical industry, committed to delivering high-quality products and services that meet the evolving needs of our customers. Our company culture is built on a foundation of trust, customer delight, Gemba (the spirit of continuous improvement), and Genki (the energy and enthusiasm to drive innovation). We are dedicated to fostering a work environment that is collaborative, inclusive, and supportive, where our employees can thrive and grow in their careers. The pharmaceutical industry is a complex and highly regulated field that requires a deep understanding of quality assurance principles, regulatory compliance, and industry best practices. As a Senior QA Analyst at Workwarp, you will play a critical role in ensuring that our products meet the highest standards of quality, safety, and efficacy, and that we comply with all relevant regulations and guidelines.

Key Responsibilities

As a Senior QA Analyst - Night Shift, you will be responsible for a wide range of activities that are critical to our quality assurance program. Some of your key responsibilities will include: Reviewing and/or approving basic and technical documentation, such as Standard Operating Procedures, Batch Production Records, and Deviation Reports, with minimal supervisory oversight. Drafting and reviewing internal Quality policies, procedures, and reports to ensure compliance with regulatory requirements and industry standards. Performing inspection of final product containers and reviewing and/or approving executed process records and data to ensure quality and compliance. Conducting Quality audit functions, including audits of lab notebooks, equipment logbooks, and vendor, supplier, contract laboratory audit questionnaires. Leading vendor, supplier, contract laboratory, and client audits to ensure compliance with regulatory requirements and industry standards. Identifying process and Quality System improvement opportunities and implementing changes to drive continuous improvement. Providing daily guidance and support to other departments, such as manufacturing and QC, on quality-related matters. Supporting Regulatory, client, and internal audits to ensure compliance with regulatory requirements and industry standards. Acting as a QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups. Promptly notifying Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Assisting with technical oversight/training for the QA team and ensuring priority task coverage. Escalating any issues as identified to Quality Management and/or departmental Management as needed. Essential and Preferred Qualifications To be successful in this role, you will need to have a strong educational background in a relevant field, such as Biology or Chemistry, and significant experience in the pharmaceutical or other regulated industry. Some of the essential and preferred qualifications for this role include: A Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience, or a Bachelor's Degree and 5+ years of experience, or an Associate's degree and 7+ years of experience. Certified Quality Auditor (CQA) certification is preferred. Excellent written and oral communication skills, with the ability to effectively communicate with stakeholders at all levels. Excellent organizational, analytical, data review, and report writing skills, with the ability to prioritize tasks and manage multiple projects simultaneously. Ability to work independently with little supervision and provide input to departmental objectives. Proficient in bolthires Excel, Word, and PowerPoint, with the ability to learn new software and systems as needed. A working knowledge of cGMP regulations for the production of drug, biologics, or vaccine products. A commitment to upholding company core values of trust, delighting our customers, Gemba, and Genki.

Skills and Competencies

In addition to the essential and preferred qualifications listed above, you will need to have a range of skills and competencies to be successful in this role. Some of the key skills and competencies required include: Strong analytical and problem-solving skills, with the ability to analyze complex data and identify trends and patterns. Excellent communication and interpersonal skills, with the ability to effectively communicate with stakeholders at all levels. Ability to work in a fast-paced environment an Apply tot his job Apply To this Job