Job Description

An exciting opportunity has arisen for a QC planner in our Biotech site, the QC Planner supports the planning of QC Testing activities to meet customer and project demands. You will ensure objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and reliable supply to our customers.

What you will do:

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

·       Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres – purchased materials, production, environmental monitoring, inventory, and stability monitoring.

·       Create a rolling QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques. The plan includes personnel and equipment assignment, and the expected sample schedule.

·       Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.

·       Monitor plan execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans if required.

·       Review mid to long-term site plans – perform scenario planning based on product and process changes, test method changes, compliance commitments, staffing levels, and equipment capability. Summarise potential laboratory bottlenecks and propose resolutions to ensure continued laboratory capability.

·       Monitor and summarise the contract laboratory service-level performance against the agreements and the assigned work. Escalate to contract owner if agreed service level is not achieved.

·       Initiates, manage, coordinate change controls and deviations for the QC department as required. Facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs are implemented

·       Be an advocate for continuous improvement.

·       Drive metrics that appropriately and accurately measure QC performance and take action to mitigate as required.

·       Apply project management concepts and techniques, as they relate to planning and test method execution, to meet established delivery timelines

·       Attend and participate in tier meetings

In order to excel in this role, you will need:

·       Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment

·       Experience using sample management system (LIMS preferred)

·       Experience in planning and project management

·       A minimum of 2-3 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations

·       Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.

·       Demonstrated ability to make and act on decisions while balancing speed, quality and risk.

·       Ability to work cross-functionally and manage relationships with stakeholders.

·       Interpret and summarise data, deal with uncertainty, manage complexity and communicate concisely.

 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

 Preferred Skills:

Job Posting End Date:

*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:R348427