Document Control Specialist
2 weeks ago
Ensure all documents are correctly filed, archived, and retrievable.
Ensure all documents meet regulatory requirements (e.g., FDA, EMA, GMP).
Participate in internal and external audits, providing necessary documentation and support.
Develop templates for controlled documents.
Revise and format documents for consistency across document types
Coordinate the review and approval process for new and revised documents.
Work with subject matter experts to ensure document accuracy and completeness.
Train employees on document control processes and procedures.
Ensure staff are aware of document changes and updates.
Identify and implement improvements to the document control process.
Stay updated on industry best practices and regulatory changes.
Additional responsibilities as assigned.
Requirements
Bachelor’s degree in a relevant field.
3-10 years of experience in document control within the pharmaceutical industry.
Familiarity with regulatory requirements and quality standards (e.g., FDA, EMA, GMP).
Experience with Veeva is highly preferred.
Strong attention to detail and organizational skills.
Excellent written and verbal communication skills.
Proficiency in document management software and MS Office Suite.
Ability to work independently and as part of a team.
Problem-solving skills and the ability to handle multiple tasks simultaneously.
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.
BenefitsOffering 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 dependentsInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.401(k) and 401(k) matchingPTO, Sick Time, and Paid HolidaysEducation AssistancePet InsuranceFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).Financial Perks and DiscountsEqual 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-RW1
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