Associate Specialist, Quality

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.

Primary Responsibilities

• Provide direct shop floor support (i.e. counts, material tagging, production event support, etc.
• Provide quality oversight of the packaging process and plant site
• Evaluate defect resolution and the control of material throughout the plant | Defect resolution, including use of statistical methods, and control of material throughout the plant site | Apply material control
• Provide guidance to packaging operation to ensure compliance with Company Quality policies, GMP's and other agency regulations for application to Wilson Operations
• Perform batch record review activities of intermediate/finished product
• Maintains 5S organization and identifies improvement opportunities
• Trends a variety of compliance performance indicators and works to drive compliance improvement
• Participates in the implementation of new programs/regulations/divisional processes at the site
• Identifies continuous improvement (business and compliance excellence) opportunities and through partnership and engagement with other functional groups, implements changes to processes
• Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations
• Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition, if required
• Participates in projects, if required
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
• Builds and promotes Team effectiveness through actions that demonstrate respect and appreciation for diverse perspectives
• Ability to interpret Company Quality Policies and Guidelines for daily application

Education Minimum Requirements

• High School Diploma AND at least Three (3) years in a manufacturing, technical, support, or Military role. OR
• Bachelor’s degree preferred in the field of science

Required Experience and Skills

• Team Building through respect and diversity
• Knowledge and exposure to fundamental theories, principles, and concepts in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems
• Strategic comprehension and appreciation of customer needs, requirements and expectations
• 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
• Technical writing capabilities and be able to compile straightforward investigations and procedures
• One to four years pharmaceutical industry exposure
• 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
• Must be able to work 3rd shift support. (Sunday-Thursday 11:30PM - 8:00AM).

Required Skills:

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. Asa federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.