Quality Assurance Specialist

Job Description

PSCBiotech provides the life sciences with essential services to ensure thathealth care products are developed, manufactured, and distributed to thehighest standards, in compliance with all applicable regulatory requirements.

Ourgoal is to skyrocket our clients’ success, and you can be a part of our team’sachievements. Employing a global team of skilled professionals and experts thatspan across strategically located offices in North America, Europe, Asia andthe Middle East, we are proud of the roles we have fulfilled to help ourclients achieve success.

TheExperience

Withoperations spanning the globe and featuring a multi-cultural team, PSC Biotechis passionate about bringing the best and brightest together in an effort toform something truly special.

When you make the decision to join our team, youwill be offered the ability to feel inspired in your career, explore yourprofessional passions, and work alongside a group of people who will value andnurture your talents.

We arefirm believers in coaching and developing the next generation of industryleaders and influencers. As such, you will not only be offered compensation andbenefits structure that rewards you, but also be provided with the tools thatwill help you grow and learn.

At PSCBiotech, it’s about more than just a job it’s about your career and yourfuture.

YourRole

We arehiring a Quality Assurance Specialist to facilitate document control, includingdocument changes and change control, document review, and QMSmaintenance.

• Supportthe review, approval, distribution, and timely processing of required qualitydocumentation.
• Coordinate the processing of newdocumentation, document updates and changes.
• Monitor document changecontrol processes, ensuring that all changes are properly documented, reviewed,and approved.
• Collaborate with cross functionalteams to ensure that documentation is accurate and maintained in accordancewith established standards and guidelines.
• Work closely with document ownersand change owners in order to ensure any deficiencies are addressed andresolved.
• Provide thorough review of internaldocuments to ensure alignment with internal standards.
• Identify andaddress any non-conformances or gaps in document control processes.
• Maintain QMS record storage.
• Prepare documents and records forrequired transfer activities.
• Identify opportunities for processimprovements within the document control function, driving efficiencies andenhancing effectiveness.
• Regularly review document control procedures andsystems, recommending and implementing enhancements as necessary.
• Communicate changes to documentcontrol processes and requirements effectively to relevant stakeholders.
• Additional responsibilities asrequired.

Requirements

• Degree in relevant field.
• 2-3 years’ experience of documentcontrol and change control management within the pharmaceutical, medicaldevice, or biotech industries.
• Strong computer skills, includingproficiency in Microsoft Office Suite. Highly skilled in Excel.
• Strong knowledge of regulatoryrequirements (GMP, ISO, QSR, etc.).
• Familiar with document controlmanagement systems.
• Familiar with CAD software andinterpreting technical drawings.
• Experienced with document indexingstructures, scanning, and high volume printing.
• Excellent communication skills bothverbal and written.
• Excellent organizational skills andattention to detail, with the ability to manage multiple tasks and prioritieseffectively.
• Ability to collaborate effectivelywith cross-functional teams.
• Analytical mindset with the ability toidentify issues, analyze, and implement solutions.

Benefits

Offeringa full suite of benefits, PSC Biotech is firmly focused on diligentlyinvesting in our employees who enable our company to fulfill our mission andachieve 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 pays100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for EmployeeAssistance 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

Estimatedpay (based on experience) : $80,000 - $100,000

EqualOpportunity Employment Statement :

PSC iscommitted to is committed to a policy of Equal Employment Opportunity withrespect to all employees, interns, and applicants for employment.

Consistentwith this commitment, our policy is to comply with all applicable federal,state and local laws concerning employment discrimination.

Accordingly, theCompany prohibits discrimination against qualified employees, interns andapplicants 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, leavesof 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 madewithout regard to an applicant’s, employee’s, or intern’s actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexualorientation), national origin, age (40 or older), disability, geneticinformation, or any other status protected by law.