Document Specialist

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.

Responsibilities

Update and route specification documents (URS, FS, DS, etc.)

Update and route lifecycle documents (risk assessments, trace matrices, etc.)

Generate, route, close commissioning protocols and incidents

Generate, route, close qualification protocols and deviations

Track and ensure on time completion of deliverables

Maintain and track all issues

Collaborate with cross-functional teams to resolve issues

Attend project meetings and provide status updates to project team

Adhere to site and global SOPs and WIs

Requirements

Bachelor’s Degree in Engineering or Science

At least 2 years of related experience

Understanding of GMP (Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience preferred)

Technical understanding of production areas (upstream/downstream)

Understanding of Engineering concepts Maintain training qualifications

Proficient at Microsoft Office Suite

Experience with Bio-pharmaceutical manufacturing

Knowledge of GMP guidelines, experience in generation of controlled documents

Demonstrate good organizational and time utilization skills

Demonstrate good written and verbal communication skills

Ability to work most of the time independently with minimal direct supervision

Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels

Risk Assessment Experience

Process Engineering Experience

Knowledge of SOPs

Benefits

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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