Complaints Specialist, Quality
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Benefits offered by this job
Job summary
Merck seeks a dedicated investigator to support vaccine manufacturing complaint investigations at West Point Quality Operations. You will perform root-cause analyses, develop CAPAs, and coordinate across teams to ensure timely responses to Health Authorities.
The role involves drafting BPDRs/AEQIRs, supporting regulatory inspections, and contributing to continuous improvement and quality governance as part of a cross-functional IPT.
Qualifications
- Bachelor’s degree in Life Sciences, Science, or Engineering preferred; candidates with other degrees considered with relevant experience.
- In lieu of a degree, minimum 4 years of GMP Manufacturing/Laboratory/regulatory experience.
Responsibilities
- Investigate customer complaints and perform second-person review to determine root cause and prevent recurrence.
- Develop CAPAs, assess event scope, and conduct product impact assessments.
- Draft/Review BPDRs and AEQIRs as required.
- Coordinate with IPT and site leadership to align with Quality approvers.
- Support tier meetings and maintain complaints trackers and governance processes.
- Contribute to continuous improvement via process improvements and investigation CAPAs.
- Assist with retention samples and batch record evaluations.
Skills
Education
Job description
West Point Quality Operations is seeking a highly motivated individual to provide complaint investigation support for vaccine manufacturing. The primary focus of the role is customer complaint investigation. The role may also include process improvements, batch data analysis, and support for regulatory inspections. Specific assignments may be focused in one operational area or span multiple areas.
- Performing investigations and second person review for customer complaints aimed to prevent recurrence, including determining the root cause, identifying
- Corrective/Preventative actions (CAPAs), identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to
- determine root cause, product impact, event scope, etc.
- Authoring notifications to applicable Health Authorities, in response to complaints, as required.
- Supporting the customer complaint work-in-progress at tier meetings/huddle, including
- assigning of workload and managing all relevant complaints trackers
- Complaints Governance meeting, Complaints Community of Practice (COP), and Health
- Authority Assessment meeting to evaluate complaints, facilitate the discussions to align with Technology and Quality approvers / representatives and site leadership.
- Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements and investigation CAPAs.
- Retention sample and batch record evaluation as applicable.
- Drafting/review/support of Biological Product Deviation Reports (BPDR) and Adverse Event Quality Inspection Reports (AEQIRs).
- Supporting team and site safety, environmental, and compliance objectives.
- Actively using and championing the use of our Company Production System tools, both in problem solving and day-to-day complaint activities
- Bachelor’s degree*. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
- * In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.
- Minimum 1 year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or Laboratory Operations, or related industry experience.
- Customer Complaint investigator or previous complaints support
- Prior Deviation Management investigator
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
Adaptability, Adaptability, Aseptic Manufacturing, CAPA Management, cGMP Compliance, Competency Management, Customer Complaint Management, Customer Complaint Resolution, Data Analysis, Decision Making, Documentation Review, Environmental Stewardship, Equipment Troubleshooting, FDA Regulations, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Operational Quality, Process Improvements, Progress Monitoring, Project Management, Quality Inspections, Quality Operations, Quality Reporting, Records Review {+ 8 more}
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
The salary range for this role is
$87,300.00 - $137,400.00
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 https://jobs.merck.com/us/en/compensation-and-benefits.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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
Regular
No relocation
No
No Travel Required
Not Applicable
1st - Day
No
NA
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