Quality Assurance Associate Specialist DSP

Job Description

An amazing opportunity has arisen for a Quality Assurance Associate Specialist DSP.

Reporting to the downstream QA lead. The QA associated 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 QA associated 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. Additionally, the QA associated 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. 

What You Will Do:

Bring energy, knowledge and innovation to carry out the following:

• Participates as the quality member on cross functional projects
• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Reviews executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors
• Provides presence on the shop floor to support compliance and data integrity
• Review & approve new and updated SOPs/ Work Instructions 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
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• QA support for Process Qualification and routine Operations
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Shift work may be required to support IPT activities.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
• Minimum 3 years 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 
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
• Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills
• Demonstrated ability to upskill/coach others
• Experience working on manufacturing shop floor
• Familiarity with GMP documentation review and/or shop floor auditing

This role will be a 12/4 shift role. 4 consecutive 12 hr shifts followed by 4 days off rolling.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/22/2024

• 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.

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