Quality Assurance Associate Specialist

Job DescriptionOur 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.We are seeking a Growth and Improvement minded Manufacturing Quality Assurance Associate Specialist that can help drive our Strategic Operating Priorities.Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic SummaryThe Quality Assurance Associate Specialist provides guidance and direction of resources and equipment pertaining to start up activities and support of the vaccine expansion facility and is responsible for all Quality related functions that directly support Durham within the expansion facility while actively participating in and embracing an empowered team culture.The individual is responsible and accountable for Quality Assurance activities that support the expansion, including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring (EM) matters, review of atypical events including assessing product impact for EM events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and reports.Key ResponsibilitiesGeneralContributes to the performance and results of the expansion project

Adapts plans and priorities to address resource and operational challenges

Decisions are guided by policies, procedures and/or business plans

Anticipates and interprets client and/or customer needs to identify solutions

Requires working with a strong Quality mindset

Is systematic, timely, and appropriately rigorous when making important decisions

Involves relevant stakeholders in a timely, appropriate manner

Proactively seeks out advice and information from others when addressing business and compliance issues that may impact other functions, geographies, etc.

Draws accurate conclusions from reports, records, and analyses to support decision-making

Shares important and relevant information with the team

Develops strong networks and relationships across functions and other organizational boundaries

Demonstrates deep understanding of customer's or stakeholder's needs, requirements and expectations

Consistently delivers on commitments to customers and stakeholders

Continuously seeks new ways to improve the delivery of products and services to customers and stakeholders

FunctionalResponsible for activities that support Good Manufacturing Practices and regulatory compliance during product manufacturing within the expansion facility | Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as Company policies and procedures

Actively participates in project suite teams

Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring

Review and approval of batch record documentation (electronic batch record comment resolution, autoclave records, review and approval of electronic batch records as applicable)

Provide Quality oversight to alarm events (non-viable particles, differential pressure, temperature, and humidity) during processing

Review incursions into classified areas for process and environmental impact and approve accordingly

Conduct periodic shop floor audits to ensure cGMP compliance

Review and approval of batch notes

Ensure proper control of materials via product investigations

Author and review Standard Operating Procedures specific to the department

Investigate results and/or laboratory atypical events

Evaluate environmental data and reports for adverse trends

Observe and audit media challenges

Support of regulatory inspections and audits

Support of operational activities and other associated Quality functions

Solutions and ImpactSupports resolution of operational problems through collaboration with peers and management

Applies appropriate risk management while adhering to cGMP requirements

Assists in decisions guided by management, policies, and procedures that impact the team’s ability to meet performance objectives

Consults with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition

Influence and DecisionRepresents Quality on the shop floor to influence cGMP compliance and ensure product quality

Explains information and persuades others in straightforward situations

Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadline

Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality

Project ManagementAccountable for quality and/or technical contribution to project team or sub-team; may manage/lead a small project team

Basic knowledge of the Quality System Model and relationships across its components

Understands quality systems relevance and importance when developing quality policies, SOPs, and guidelines

EducationBachelor or Master Degree in Biology, Biochemistry, Chemistry or other relevant discipline

RequiredWork independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

One year (combined intern, co-op or full time) in pharmaceutical operations, technical services, and/or quality operations

Demonstrates flexibility, ability to manage multiple priorities, interpersonal, technical aptitude and problem-solving skills

PreferredcGMP experience in a sterile, bulk or finished pharmaceutical environment

Experience with process or environmental monitoring performance qualification

Experience with SAP systems | Change Control systems and/or GLIMS

ScheduleOperates on 12-hour rotating night shifts including weekends and holidays | Initial training will take place on day shift

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., 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 APPLICANTSIn 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.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA Supplement​OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe 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:Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:On-SiteShift:3rd - NightValid Driving License:NoHazardous Material(s):Number of Openings:2Requisition ID: R193601