Position Overview – Basic Functions & Responsibility
The SENIOR LABORATORY ANALYST is primarily responsible for the prompt and accurate analyses of bulk products and finished products, environmental sampling and testing of immediate contact packaging components according to our company’s quality standards, GLP and Data Integrity Principles.
Additional responsibilities include the oversight and management of Quality Control related projects (such as product method transfer, technology enabled global projects for the laboratory); the implementation, sustainment and periodic review of quality management systems and procedures and the trending of data to identify risks and optimisation projects.
Assists QC Lead in enhancing compliance posture of the Laboratory by assuming responsibility and being accountable for all the primary activities listed below.
Primary Activities
Accurate analysis of Finished Products and packing components to ensure they are tested according to our company’s quality standards, regulatory requirements and GLP and within the committed lead times.
Prompt and timeous execution of testing by planning and organising daily workload in order to optimally utilize available time.
Ensures that Calibrations and Performance maintenance activities are carried out promptly and timeously according to our Manufacturing Division’s SOP’s and OOS / OOT results are reported to the QC Lead immediately.
Takes responsibility for maintenance and operation of the HPLC’S according to relevant SOP’s and training provided; assists with troubleshooting.
Comply with Laboratory housekeeping requirements and Chemical Hygiene Plan guidelines.
Assess chromatograms for accuracy and acceptability before processing results and reporting abnormal occurrences immediately.
Evaluates results against release criteria – promptly reports any atypical or OOS results
Initiates and coordinate Deviations and root cause analysis for OOS test results
Adheres to Data Integrity principles
Initiate Change Controls for the Laboratory
Implementation, review and training of Lab SOP’s as per regulatory requirements / global procedures
Promptly reports, and where applicable, manages any equipment related issues where unplanned maintenance is required and initiates necessary documentation when required
Ensures all EHS requirements are implemented and adhered to safety rules and adhere to at all times Maintenance of the DI Water system
Assists in any remediation required for lab systems compliance
Participates in method transfer activities including documentation and report writing
Participates in remediation resulting from all internal and external audits.
Participates in company training programs to support the company vision as well as any other training to ensure effective fulfilment of duties.
Implementation of periodic trending of data to determine OOT situations and collaborate to implement corrective actions.
Participate in MPS activities for the QC Laboratory
QUALIFICATIONS/ SKILLS
A Tertiary degree in Chemistry or a diploma in Analytical Chemistry (BTech preferable).
A sound knowledge of analytical and instrumental techniques
Sound knowledge of HPLC
Responsible, accountable and reliable
Strong investigation and problem solving skills
Efficiency in Windows applications, Microsoft Word, Excel and Power Point, MS Teams
Ability to work accurately and efficiently
Agile and pro-active
Technical, mechanical and mathematical skills
Good verbal and written communication skills
EXPERIENCE REQUIRED
Minimum 3 years’ experience in a Pharmaceutical environment & Quality Control Environment
Experience in our company’s Production Systems is an advantage
Operation and management of GLIMS (Laboratory Information Management Systems)
Laboratory related project management an advantage
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Domestic
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R97363