Complaints Specialist, Quality

3 weeks ago

West Point, United States Merck Sharp & Dohme Full time

**Position Overview - Basic Functions & Responsibility**
**The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor. The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations and customer complaints. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.

**Primary Activities**:
Becomes fully trained in relevant Standard Operating Procedures (SOPs) and competency-based activities.

Learns cGMPs, the manufacturing process, and our company's quality systems, including SAP, LIMS and electronic logbook, laboratory data, and batch record platforms.

Provides presence on the shop floor to support compliance and data integrity.

Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.

Collaborates with cross-functional team members to ensure batches are ready for release by appropriate due dates and executes the appropriate quality checks and SAP transactions required.

Responsible for routine auditing of GMP practices, documentation, and data.

Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.

Performs review/approval of new and updated SOPs and Controlled Job Aides.

Actively participates in the Tier process and use this forum to make concerns visible and to partner with the functional area on resolution.

Responsible for review/approval of new and updated Master Batch Records

Performs review/approval of Qualification documents as needed.

Cross trains to support other functional quality areas including deviation management, customer complaints, documentation review, environmental monitoring, and qualification activities.

Provides support to internal audits and regulatory inspections as needed.

Fosters a customer service and win-as-one-team attitude within the functional area.

**Required Education**:

- 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, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

**Required Experience and Skills**:

- 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 in a laboratory, manufacturing, science related or regulated setting.
- Evidence of leadership skills coupled with good oral and written communication skills.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

**Preferred Experience and Skills**:

- Experience in quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents.
- Experience with Aseptic gowning may be required.
- Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.
- Demonstrated ability to upskill / coach others.
- Familiarity with GMP documentation review and/or shop floor auditing
- Titers may be required.

**NOTICE FOR INTERNAL APPLICANTS**

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

MSJR

VETJOBS

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated agai

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