Job Description
Position Summary
The Compliance Operations Associate Specialist provides foundational support for compliance operations activities, including audit and inspection readiness, controlled documentation, and proactive monitoring of compliance tasks. This entry-level role performs structured assignments using established procedures and standard work instructions. The incumbent supports internal stakeholders by maintaining accurate records, coordinating routine requests, and escalating issues or concerns to more experienced team members. This position is designed for individuals developing strong conceptual knowledge of compliance theories, practices, and procedures.
Key Responsibilities
- Support day-to-day compliance operations activities in accordance with established procedures, templates, and guidance.
- Assist with audit and inspection preparation by organizing records, compiling supporting documentation, tracking requests, and coordinating follow-up actions.
- Maintain compliance documentation, logs, trackers, and repositories with accuracy, completeness, and timeliness.
- Support document control activities, including collection, routing, filing, archiving, and retrieval of controlled records and evidence.
- Respond to standard internal requests from cross-functional partners, customers, and stakeholders with direction from senior staff as needed.
- Identify missing information, discrepancies, or potential compliance issues and escalate concerns appropriately.
- Assist with routine proactive compliance activities such as monitoring deadlines, completing checklists, and tracking commitments or action items.
- Contribute to the maintenance and improvement of compliance tools, trackers, templates, and job aids under guidance.
- Support preparation of presentations, reports, and summaries related to compliance activities as assigned.
- Perform other related duties as assigned in support of the compliance operations function.
Essential Functions
- Perform structured work assignments using existing procedures to solve routine or standard problems.
- Work within functional guidelines and direction to achieve objectives and meet deadlines.
- Respond to standard requests from internal partners and stakeholders.
- Highlight concerns or issues and formulate potential solutions with direction.
- Contribute to technical and/or business deliverables with supervision and oversight.
Required Qualifications
- Bachelor’s degree in business, life sciences, legal, regulatory, quality, or related field; or equivalent education and experience.
- Strong organizational skills and attention to detail.
- Ability to follow written procedures and work instructions accurately.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Ability to manage multiple routine tasks and meet deadlines in a structured environment.
- Demonstrated ability to work collaboratively as part of a team.
Preferred Qualifications
- Internship, co-op, or up to 2 years of experience in compliance, quality, audit support, document control, regulatory operations, or related field.
- Exposure to audit and inspection readiness, records management, or controlled documentation practices.
- Familiarity with SOPs, document lifecycle processes, and compliance tracking tools.
Knowledge, Skills, and Abilities
- Developing knowledge of compliance theories, practices, and procedures.
- Ability to apply standard processes to routine tasks.
- Strong attention to detail and data accuracy.
- Basic problem-solving skills and willingness to ask questions.
- Ability to handle confidential and sensitive information appropriately.
- Strong teamwork skills and professional judgment.
- Ability to identify issues and escalate appropriately.
Competencies
The successful candidate will:
- Build competence through structured work assignments and established procedures.
- Seek input to understand pain points and opportunities for improvement.
- Support team effectiveness through respectful, reliable collaboration.
- Contribute to technical and functional deliverables with direction.
- Learn foundational compliance concepts through on-the-job assignments.
Working Relationships
This role interacts with:
- Compliance Operations team members
- Quality, Regulatory, and Audit/Inspection stakeholders
- Cross-functional internal partners
- Document control and records management teams
- External auditors or inspectors, as applicable, under supervision
Physical and Other Requirements
- Ability to work in a standard office or hybrid environment.
- Ability to sit, use a computer, and participate in meetings for extended periods.
- Occasional flexibility required to meet audit or inspection timelines.
# eligibleforERP
# PRD
Required Skills:
Biological Sciences, Biopharmaceutical Operations, Client Communication, Compliance Research, Confidential Data Handling, Documentation Controls, Document Controls, Engineering Standards, Estimation and Planning, Life Science, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Presentation Preparations, Sterile Filling
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
The salary range for this role is
$71,900.00 - $113,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
08/12/2026
