Manager, Off Shift Quality Control

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Under the direction of the Associate Director, is responsible for providing guidance and supervision to hourly employees to complete testing and testing support activities. Responsible to motivate, train and resolve problems for his/her team while maintaining a compliant and safe environment. Uses team work and good communication skills to administer personnel policies in accordance with the local bargaining agreement.

Additional Responsibilities

• Activities involved in conducting testing and/or assaying of, validation, raw material, process intermediates and finished product samples, and is knowledgeable in the analytical techniques for the laboratory(s) they support | Technologies include those in the disciplines of, Virology, Biochemistry or other Biological Sciences

• Supervision of hourly employees performing testing which includes scheduling of work assignments based on priorities, being knowledgeable of cGMP, administration of local bargaining agreement, company personnel policies, OSHA requirements and company safety procedures

• Promotes teamwork and open communication

• Updating SOPs, Process Specific Training Modules, Test Methods, etc.

• Training personnel to ensure employees are competent and qualified to perform duties, while complying with departmental policies and procedures

• Conducting lab work accurately and in a timely fashion | Critically evaluating data generated and recommending acceptance or rejection of samples

• Maintain records, develop productivity improvement plans, maintain adequate inventory of supplies, training records, tracking functions such as corrective actions, special projects, etc.

• Cooperates with our Company Manufacturing Division as required to resolve technical problems

• Supports deviation investigations, out-of-trend results, and test failures associated with product manufacture, release testing, and stability testing

• Investigating safety and environmental incidents and near misses | Model a safe and compliant culture throughout the laboratory

• Improve laboratory quality and to continuously improve assays using lean principles | Support regulatory inspections and train Laboratory Operations managers and/or technicians

Education Requirements

• Bachelor degree in Biology, Microbiology, Virology, Biochemistry, or associated field

Required Experience and Skills

• Minimum three years of post-degree laboratory, manufacturing, or quality control

• Principled, good and strong verbal and written communications

• Work in a Team setting

• Good interpersonal and supervisory skills

• Demonstrated ability or aptitude for continuous learning and analytical problem solving

Preferred Experience and Skills

• Biological assays and/or biochemistry based assays

• cGMP regulations

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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., Rahway, 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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Residents of Colorado:

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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):

Requisition ID:R222679