Hiring company: Merck
Job Description
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Employee must show ability to perform routine assignments and develops competence by performing structured work assignments. Ability to use existing procedures to perform routine testing. Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts. Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions. Builds and promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives. Demonstrates appreciation of customer needs, requirements, and expectations. Seeks new ways to improve services to customers. Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas. Works to develop new skills and abilities. Readily accepts performance feedback and incorporates this feedback into future performance. Assists other team members, including helping with developmental activities. Learns to use new problem-solving tools to surface and solve issues.
Applies general knowledge of company business developed through education and past experience. Ability to interpret our Company Quality Policies, Guidelines and Testing Procedures for daily application. Comprehends and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses a basic knowledge of theories, practices, and procedures in the Quality Control discipline, including the knowledge and understanding of pharmaceutical testing. Active with developing technical writing capabilities and is able to compile straightforward investigations and procedures, and recommend scientifically sound corrective actions. Possesses a basic knowledge and ability to operate lab instrumentation required to complete job tasks. Uses existing procedures to perform routine testing. Ability to independently reply to basic requests for data and trending of data. Develops small scale presentations and presents to own work team or small groups with the assistance of others. Has limited decision-making authority and works within technical guidelines/direction to achieve objectives and meet deadlines. Accountable for technical contribution to work or project team. Requires moderate to little supervision.
Primary Responsibilities
Supports continuous improvement and sustainability of implemented changes and identifies and implements continuous improvement changes within the laboratory
Ensures work is completed right first time and participates in root cause and corrective action identification and documents investigations
Participates and leads, when required, Tier I and Tier II activities
Demonstrates working knowledge of product performance and testing methodology
Responds to and remediates audit observations
Demonstrates working knowledge of equipment and ensures proper usage of equipment occurs
Participates in coordination of testing activities within work team
Tests and interprets results for any of the following: raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples
Maintains compliance by following corporate policies/guidelines and local SOP’s
Interprets compendial and internal monographs, NDAs, and company Quality Standards
Provides analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD)
Assures laboratory compliance by adhering to cGMP, CFR, and other agency regulations and revises laboratory procedures as required
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory
Maintains 5S organization throughout the laboratory and identifies improvement opportunities
Participates in project activities designed to improve the business operation of the laboratory, the compliance posture of the laboratory, the skills and capabilities of the laboratory, etc.
Performs Purified/Potable Water, Compressed Air Utility and Environmental Monitoring sampling and testing
Supports GLIMS as necessary
Performs Microbial Enumeration Testing per USP <61> & <62> and any other work as assigned by manager
Education Requirements
B.S. degree in a science field required, preferably biology, microbiology, or biological sciences
Required Experience and Skills
- Good technical writing skills and high attention to detail
- One to three (1-3) years laboratory testing or equivalent educational laboratory
- Work independently and within a team environment
- Good communication
- Aseptic techniques
Preferred Experience and Skills
- Knowledge of cGMPs
- Root cause analysis methodology
- Compendia microbiological testing methods
- Analytical method transfer
- Sterility testing
- Mycobacterium/Mycoplasma testing
- Growth Promotion
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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
Pay Transparency Nondiscrimination
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not SpecifiedShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Number of Openings:
1