Responsibilities

Job Description

Under general supervision, this position assists with:

• Maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines and site procedures
• Processing document change controls
• Management of the site’s Finished Product Samples Inventory including retention management and submission to the CVB
• Inspection, review and release of incoming raw materials for production, ensuring compliance with regulatory and site requirements for use
• Coordinating with site stakeholders and third-party vendors to maintain supply chain records, provide information for supplier audits, and manage incoming supplier change controls for site review.
• Reviewing documents against regulatory requirements for compliance and updates as required
• Maintaining and operating within critical quality systems such as change control, document management, deviation management, etc.
• Review of batch records and test records
• Maintenance of seed stocks
• Performing disposition and movement transactions in SAP
• Annual outline review management

Provides direct support during audits and regulatory inspections

• Supports vendor audits
• Conducts/participates in self-inspection audits
• Assists with special projects, such as Quality Work Plans
• Assists with external audits if required
• Uses electronic programs such as Word and Excel to create and maintain official controlled documents managed by the QA department
• Performs general QA activities including but not limited to:
• Organization and accurate filing of controlled documents
• Cleaning of QA areas, as needed
• Performs other activities in support of the Quality Department and site, as needed

Education Minimum Requirements

• High school diploma or equivalent with 7 years relevant work experience and skilled at verbal and written communication
• Prefer Bachelor’s degree in a related field with at least 2 years relevant work experience or a non-related Bachelor’s degree with some relevant experience or Associate’s degree in a related field with 5 or more years of experience

Required Experience

• Ability to work successfully in a team-oriented environment and coordinate multiple tasks
• Ability to work independently with minimal direct supervision
• Ability to effectively follow Standard Operating Procedures and other procedural guidelines
• Ability to manage multiple projects simultaneously and produce timely results
• Strong organizational skills with close attention to detail
• Strong computer skills with MS Office environment experience
• Excellent communication and writing skills
• Ability to communicate effectively with all levels of colleagues between multiple departments
• Willing to travel up to 5%

Preferred Experience

• Previous experience with USDA or GMP manufacturing environment and/or quality systems highly preferred
• Previous experience with SAP inventory management systems
• Experience or knowledge of Lean process initiatives, 6-Sigma or similar programs

MSJR

• 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.

Requirements

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. As a 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.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Salary and Benefits

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US Salary Range

$63,900.00 - $100,500.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

Additional Information for Residents

• 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

• Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Not Applicable
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): n/a

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.

Requisition ID:

R346966