Validation and Operations Specialist
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 teams 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 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 its about more than just a jobits about your career and your future.
Your Role
Were seeking a versatile professional who thrives at the intersection of validation technical writing project coordination and executive support. Youll own documentation and validation deliverables keep crossfunctional projects on track and provide highimpact support to senior leadership. This is a fully remote position with collaboration across U.S time zones.
- Develop author and maintain validation documentation (e.g. URS/FDS IQ/OQ/PQ protocols test plans risk assessments reports).
- Partner with SMEs to ensure documentation meets regulatory compliance and internal quality standards.
- Track validation activities deviations CAPA items and change controls; maintain auditable records and version control.
- Write and edit SOPs work instructions technical guides and partner/clientfacing documentation.
- Translate complex technical concepts into clear accurate content tailored to audiences (engineering QA/RA business stakeholders).
- Establish templates style guides and document workflows to improve consistency and speed.
- Manage calendars briefing materials travel logistics and confidential communications for one or more executives.
- Prepare meeting packets decision memos and executive dashboards; anticipate needs and unblock decisionmaking.
- Gate keep and prioritize inbound requests; streamline workflows and information flow.
- Assist with light content development (blog posts onepagers slide decks) brandaligned edits and casestudy packaging.
- Help coordinate campaigns events/webinars and CRM updates; track basic performance metrics.
Requirements
- 37 years of blended experience across validation/quality technical writing project coordination and executive assistant duties.
- Demonstrated proficiency in writing technical protocols SOPs and/or regulated documentation; strong attention to detail and version control.
- Solid project coordination skills: scheduling RAID logs stakeholder updates and meeting facilitation.
- Executive support experience: calendar and travel management briefing prep discretion with sensitive information.
- Excellent written and verbal communication; ability to tailor messages to technical and nontechnical audiences.
- Comfort with productivity/PM tools (e.g. Microsoft 365 SharePoint Teams OneDrive Planner or equivalents); basic familiarity with CRM or marketing tools is a plus.
- Marketing exposure (content edits collateral basic analytics) preferredwilling to train if other capabilities are exceptional.
- Selfstarter organized and resourceful; thrives in a remote fastpaced environment.
- Must be able to work during standard U.S time zone hours.
Benefits
Equal Opportunity Employment Statement
PSC Biotech 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 applicants employees or interns 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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Company Industry
IT Services and IT Consulting
Key Skills
- Financial Services
- Information Technology
- Cost Control
- Corporate Risk Management
- Law
