QC Analyst

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

• Responsible for test record, raw data, and document review.
• Ensure Good Documentation Practices (GDP) are followed on controlled documents.
• In-depth understanding and adherence to the Quality System requirements established by the client.
• Demonstrates full understanding of routine laboratory procedures.
• Ensures procedures and policies are accurately followed by QC analysts.
• Applies extensive technical expertise and has knowledge of related disciplines/processes (HPLC/UHPLC, GC, IR, UV, AA, KF, USP monograph procedures and in-house testing procedures).
• Assess and review laboratory raw data (Chromatograms, spectra, etc.)
• Works closely with staff on OOS, OOT, deviation, abort/Invalid, quality event and/or CAPA investigations, reports, and root cause analysis for all testing that occurs within the client and contract laboratory for GMP production, studies, and investigations.
• Write and/or revise and/or review Standard Operating Procedures (SOPs) and in-house procedures and protocols.
• Provides leadership, guidance, and training to junior colleagues on a regular basis.
• Responsible for ensuring QC analysts follow cGMPs.
• Support the development and execution of validation studies and research projects.
• Maintains a safe and clean laboratory environment.
• Follows Good Documentation Practices (GDP).
• Demonstrates knowledge and understanding of Pharmaceutical GMPs and excellent cGMP documentation skills.

Requirements

• A bachelor's degree in a scientific discipline is preferred and at least 5 years of direct applicable experience in the pharmaceutical/biotech industry or master's degree with at least 3 years of experience in the pharmaceutical/biotech industry.
• Experience with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
• Proficient in Microsoft Office's Excel, PowerPoint and Word.
• Ability and willingness to travel is preferred.

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

Annual Salary Range (dependent on experience) $93,600-$98,526

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.

#LI-AS1