Job Description

A fantastic opportunity has arisen for a Senior QA Specialist in the site Quality team.

The Senior Quality Specialist is a self-directed, decision maker in the Drug Substance and Drug Product Intermediate facilities and provides input into achieving the Quality deliverables and ensures that the site meets all Manufacturer’s License requirements for clinical and commercial production and is audit ready for both customers and agency inspections. Uses sound judgement to make good decisions based on information gathered and analyzed.

Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance. Team Leadership: is accountable for assisting in the coaching and upskilling of the Quality Specialists in the Quality team.

Teamwork skills: Interacts with people effectively. Able and willing to share and receive information. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.

What you will do:

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

Part of a team that ensures timely and effective completion of the Quality core functions, including;

Application of Quality Risk Management to all process and systems.
Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.
Documentation preparation, review & approval process required to support IPT operations.
Prepare/Review Annual Process and System Reviews.
Raw material (API, SDI and excipient) and component release, targeting
Batch review and release and deviation management process,
Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
Provide detailed knowledge of quality systems and ensure that root cause is identified and corrective actions as appropriate are completed.
Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
Deliver on System Improvements

Ensure changes controls raised are documented, assessed, and completed.
Participate in the generation and communication of quality metrics.
Preparation, review & approval of site documentation including policies, procedures, associated reports and annual reviews, as required to support site quality systems.
Participation in the internal audit program.
Participate in the preparation for and hosting of regulatory and customer audits.
Participate/Lead in Quality and site projects that may arise including New Product Introduction.
Participate as a team member in the site new product introduction teams established to manage the transition of new products from Phase II2 through to PPQ and supply.
Delegate for the Associate Quality Director as required.

What skills you will need:

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

Knowledge of Quality IT systems desirable (e.g. SAP, LIMS, Veeva, QSAT, Quality Docs)
Knowledge and demonstrated expertise in Lean / Continuous Improvement.
Proven Leadership Skills.
Experience and knowledge of GMP Requirements for Electronic/paper free operations.
Experience in High potency manufacturing / Spray drying / Laboratory GMP / Project Management is desirable.
Degree or post-graduate qualification in Science, Pharmacy or equivalent.
Eligible to act as a Qualified Person, desirable but not essential.
Project Management.
Validation.
Facility Qualification is desirable.
Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately.
Adapts to changing work environments, work priorities, organizational needs and diverse people.
Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self- direction.

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.

Required Skills:

Adaptability, Adaptability, cGMP Regulations, Change Management, Communication, Corporate Productions, Corrective Action Management, Deviation Investigations, Deviation Management, Documentations, GMP Compliance, Good Automated Manufacturing Practice (GAMP), Internal Auditing, Leadership, Manufacturing Quality Control, Pharmaceutical Quality Assurance, Pharmacy, Product Disposition, Production Support, Project Management, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Standards, Raw Materials {+ 4 more}

Preferred Skills:

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:

03/23/2026

*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.

Sr. Spclst, Quality Assurance

Job Description