Job Description

We are currently seeking a Quality Specialist to join our biotech facility. As a Quality Specialist you will provide direct quality support to a production area as part of a Quality IPT (Integrated Product Team). The Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality.

What you will do:

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

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aids
• Actively participates in the Tier process and use this forum to make issues 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.
• Serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation when required.
• Participate as the quality member on cross functional projects
• 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
• Coach and guide colleagues to ensure documentation is completed right first time, and to ensure compliance with cGMPs and regulatory requirements
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools and MPS (Our Company Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

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

• Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
• Minimum 5 years of relevant experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• Understanding of QA operations is an advantage
• Evidence of leadership skills coupled with excellent and written communication skills
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, 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):

Required Skills:

Adaptability, Adaptability, Aseptic Manufacturing, Biopharmaceutical Industry, Capital Projects, cGMP Compliance, Change Management, Data Analysis, Data Integrity, Decision Making, Documentation Review, FDA Regulations, GMP Compliance, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Management Process, New Product Development, New Product Introduction Process, Operational Efficiency, Pharmaceutical Process Engineering, Quality Assurance (QA), Quality Inspections, Quality Management, Quality Operations {+ 4 more}

Preferred Skills:

Job Posting End Date:

07/4/2025

*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.