Job Description

Job Description

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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

As part of our Company's Quality Operations Organization, the Durham site Quality team is seeking a highly motivated individual for the Quality Operations BioAssay Laboratory. This position is accountable for performing lot release testing in compliance with standard operating procedures, safety, and cGMP regulations. Primary duties of this position will focus on the daily quality control lab operations.

Responsibilities

* Support routine release testing

* Complete appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms

* Enter data evaluated for compliance to specifications and report abnormalities.

* Maintain lab areas and equipment to GMP standards including routine cleaning and decontamination of lab benches, biosafety cabinets, and other equipment

* Participate in equipment and instrument installation, operation, and performance qualification

* Maintain current training on all assigned procedures to include read & comprehend, skills development and classroom training activities as required

* Maintain close communication and interaction with QC management and staff to ensure on-time completion of assigned activities

* Comply with company health and safety procedures and practices.

* Author SOPs and technical documents

* Other duties as needed

Education Requirement

* Bachelor of Science in Biochemistry, Biological Sciences, Chemistry or related field

Experience and Skills

Required

* Minimum three years in a cGMP environment in the pharmaceutical industry

* Hands on experience in moisture testing, pH and biochemical/cell based assay

* Demonstrated technical writing ability; able to author protocols and reports

* Demonstrated structured problem-solving skills; able to drive investigational support activities to remediate method-related investigations and performance issues

* Direct experience in authoring and review/approval of SOPs

* Strategic and effective organizational, analytical, and communications skills

* Flexible and able to manage multiple assigned tasks

* Demonstrated time management, organizational and prioritization skills

* Attention to details and good documentation skill

* Function in a fast-paced team environment to meet critical production timelines

Preferred

* Quality Control laboratory settings

* Knowledge of Laboratory systems (GLIMS, SAP)

DurhamQuality

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 thats 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.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Number of Openings:

1
Requisition ID:R101709