Quality Compliance Associate

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Posting Title: Quality Compliance Associate

Brief Description:

The Quality Compliance Associate provides core compliance functions and project support for the Quality Compliance department including SOP document preparation and updates, training file maintenance, and compliance audits. Audit support includes, but is not limited to, audit scheduling, logistics, and document preparation and support. The Quality Compliance Associate provides additional assistance with special projects including CAPA document management, compliance-related continuous improvement projects and training document creation/updates within the Learning Management System (LMS). This position may also provide administrative support to the Quality Compliance department as appropriate.

Specific job duties:

• Ensure SOPs and corresponding test assessments are created and updated within a timely manner according to internal policies and procedures. Ensure appropriate formatting of SOP documents.
• Support and management of the Quality Management Systems (QMS) to include:
  • Problem Notification Forms (PNFs)
  • Corrective/Preventive Actions (CAPAs)
  • Compliance Audits (Client/Vendor/Internal)
  • Document Management (SOPs/PSPs/WIs/Job Aids)
• Support SOP review and approval process as deemed appropriate
• Provide Regulatory/Client Audit Support
  • Assist with audit scheduling and audit calendar maintenance
  • Assist with meeting coordination/logistics
    • CDA Requests
    • Auditor Code of Conduct
    • Setting up internal trackers and portals
    • Setting up and providing secure Box access for auditor(s) when required
  • Assist with Quality Compliance documentation review prior to and during audit.
  • Ensure audit reports and responses are stored as per UBC record retention procedures.
• Provide assistance with Problem Notification Form (PNF) and CAPA data entry and administrative review when required.
• Provide administrative support (i.e., agenda, minutes, metrics) for the Quality Assurance department.
• Support the maintenance and archival of all QA records.
• Assist in department-related special projects.
• Assist with Learning Management System document management where needed.
• Other duties as assigned.

Supervisory Responsibility:

N/A

Desired Skills and Qualifications:

• Bachelor’s degree or equivalent work experience.
• 1 – 2 years of relevant experience preferably within a regulated pharmaceutical and/or medical device industry.
• Proficient PC knowledge required including Microsoft Office Suite and Internet, SharePoint.
• Excellent written and oral communication skills essential for professional phone and email interactions.
• Good interpersonal skills.
• Continual attention to detail in composing, typing and proofing materials, establishing priorities and meeting deadlines.
• Ability to work independently.
• Strong organizational and time management skills.
• Ability to interact and work within a team environment.
• Ability to keep sensitive information confidential.
• Preferred experience working within the bounds of Standard Operating Procedures/policies.
• Preferred experience providing project support.

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• Flexible work environment
• Discretionary PTO (Paid Time Off) OR 20 days (about 3 weeks) of PTO
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

#LI-REMOTE

#LI-HB1