QA Associate

The work we do at BioTechnique has never been more important-and we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what's possible.

BioTechnique® is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services. BioTechnique's project management and client services staff work closely with our clients to meet all manufacturing needs. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and optional lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team's expertise to work with our clients to create a process design for their product that suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At BioTechnique, it's about more than just a job-it's about your career and your future.

Your Role

The Quality Assurance Associate is responsible for ensuring compliance with all quality standards and guidelines. The QA Associate will analyze systems and procedures, identify any potential issues, and work with the Quality Team to ensure process improvement and resolutions.

• Develop and assist in Quality Systems and Meteorology systems as needed.
• Assist in software validation and runs quality systems accordingly.
• Support of documents for SOPs, test methods, raw material specification, protocols, and related control documents.
• Follows safety initiates and assist upper management with the compliance of SOPs and specifications
• Perform a variety of activities to ensure compliance with applicable regulatory requirements.
• Assists to maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
• Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) daily.
• Performs independent technical review of documentation during and post-execution of cGMP activities.
• Ensures all specifications are met and that applicable requirements are completed and acceptable.
• Analyzes and reports findings to appropriate departments.
• Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of Quality Systems.
• Implements continuous improvement efforts as it relates to QA activities.
• Other duties are required.

Requirements

• Requires a Bachelor or higher degree from an accredited four-year university, preferably in sciences or engineering.
• 3-5 years of relevant experience. Quality Assurance experience preferred.
• Experience following regulatory guidelines for pharma industry and cGMPs.
• Experience with quality management systems.
• Must be detail-oriented and able to demonstrate a high standard of integrity.
• Must have a desire to demonstrate excellence by setting high standards.
• Must have an understanding and application of QA principles, concepts, industry practices, and standards.
• Strong knowledge of relevant regulations and guidance required in order to act as a resource for colleagues.
• Strong verbal, technical writing, time management and interpersonal skills are required.
• Computer competency is required.
• Strong independent judgment and decision-making abilities required.

Benefits

Offering a full suite of benefits, BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Equal Opportunity Employment Statement:

BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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