Complaints Specialist, Quality

Merck & Co.; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical benefits

Dental & vision

401(k) plan

Annual bonus

Job summary

Merck & Co. in West Point seeks a diligent investigator to support customer complaint investigations in vaccine manufacturing. You will establish root causes, participate in CAPAs, evaluate product impact, and draft internal and health authority communications where required.

The role involves cross-functional collaboration, batch record evaluation, and support for inspections. A life sciences or engineering background with GMP experience is preferred, focusing on quality systems and continuous

Qualifications

• Bachelor's degree in life sciences, engineering or related field; equivalent GMP experience accepted.
• Minimum 1 year post-degree GMP/manufacturing or quality-related experience.

Responsibilities

• Lead investigations and second-person reviews for customer complaints to prevent recurrence.
• Identify root cause, scope, events and contribute to CAPAs and product impact assessments.
• Draft notifications to Health Authorities as needed and support regulatory communications.
• Maintain complaints trackers and support tier meetings and governance.
• Collaborate across IPT areas to drive continuous improvement and problem solving.

Skills

CAPA Management

cGMP Compliance

Data Analysis

Documentation Review

Problem Solving

Education

Bachelor's degree in Life Sciences or Engineering

Equivalent GMP experience 4 years

Job description

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

Required Education

• 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.

Required Experience

• 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.

Preferred Experience and Skills

• Customer Complaint investigator or previous complaints support
• Prior Deviation Management investigator
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

Required Skills

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}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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 .

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

NA

Job Posting End Date

09/9/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R415336