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Form of workJob Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® 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 compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring a motivated and detail-oriented QA Specialist in Houston, TX. The position will play a crucial role in ensuring the highest standards of quality and compliance in lot control, disposition, batch review, batch release documentation, and overall documentation within the pharmaceutical industry.
- Perform comprehensive reviews of batch records to ensure accuracy, completeness, and compliance with cGMP and regulatory standards.
- Work closely with production and quality control teams to address any discrepancies or deviations identified during batch review.
- Release of finished product batches, ensuring alignment with quality standards and regulatory requirements.
- Maintain accurate and up-to-date records of batch release activities.
- Establish and maintain a robust documentation system, including standard operating procedures (SOPs) and work instructions.
- Conduct periodic reviews of documentation processes to identify areas for improvement and implement necessary changes.
- Support lot control processes to ensure traceability and accountability throughout the product lifecycle.
- Collaborate with cross-functional teams to investigate and resolve lot-related and disposition issues promptly.
- Continuously verify compliance with established procedures and specifications.
- Additional responsibilities as required.
Requirements
- Bachelors degree in a relevant scientific discipline.
- 3-5 years of quality assurance experience in the pharmaceutical industry.
- In-depth knowledge of cGMP regulations and other relevant quality standards.
- Proven experience with batch review, batch release, and batch documentation.
- Experience in lot control and disposition is preferred.
- Strong analytical and problem-solving skills with attention to detail.
- Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
- Ability to thrive in a fast-paced and regulated environment.
- At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
Offering a full suite of benefits, PSC Biotech™ 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
PSC 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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