Spclst, Quality Assurance

Job Description

An amazing opportunity has arisen for a Spclst, Quality Assurance.

What you will do:

• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Perform and review complaints and deviation investigations, change controls and CAPA's.
• Create and maintain assigned SOPs.
• Compile data for reports and presentations, provide data interpretation and draw conclusions.
• Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
• Support product recalls and stock recoveries as appropriate.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilize this network to help resolve comments and issues that arise during audit and review.
• Identify compliance gaps and make recommendations for continuous improvement.
• Assist in the induction process for new starters and training of other staff.
• Generally, follow standard procedures and consult with manager/supervisor on exceptions.
• Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
• Represent the department on cross-functional teams.
• Additional activities as assigned by the manager/supervisor.

What skills you will need:

• Degree in a Science or Engineering discipline plus some industrial experience.
• Alternatively, considerable industrial experience.
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic/paper-free operations.

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: Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 03/26/2025

*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: R339862