Associate Specialist, Operations

Job Description

As part of our company's Sterile Manufacturing and Packaging Organization, the Wilson team is seeking a highly motivated individual to serve as a Specialist within the Operations team. -In this role, you must be able to work efficiently in a fast-paced environment and be hands-on with operations and process activities.

The Specialist will provide support for sterile manufacturing and packaging operations in a range of capacities including problem solving, root cause analysis, strengthening compliance posture and inspection readiness, investigating and authoring deviations related to unplanned events, among others.

The Specialist must demonstrate strong collaboration and communication skills to enable interfacing with both internal and external contacts, technical writing, rapid disciplined decision making and work prioritization skills.- The Specialist will support critical site project initiatives and will be involved in developing and implementing corrective actions and preventive actions. -Enthusiasm for continuous learning is a requirement.

Hours for position: 3rd Shift 2200-0630 Sunday-Thursday

PRIMARY ACTIVITIES -------------------------------------------- -------------------------

• Assist in the review of preventative maintenance (PM) documentation
• Assist in the review of production batch documentation.
• Assist in the review of SAP inventory accuracy
• Assist with the development of sample management
• Author and revise standard operating procedures to support continuous improvement efforts and site initiatives
• Author incident and investigation reports in compliance with GMP's and all site and global procedures
• Author special instructions and re-packaging instructions in compliance with GMPs and all site and global procedures
• Facilitate tier meetings to ensure alignment with business goals
• Support internal audits, Quality Risk Assessments, external regulatory inspections, and other site initiatives requiring Operations expertise
• Support or lead continuous improvement projects and/or change controls, applying OPPS & 8 Step methodologies to analyze errors and process failures.

Support or lead the development and implementation of Operations related corrective and preventative actions.

Support shift leadership, collaborating with Shift Manger and Lead(s) to manage team activities and address operational challenges.
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SKILLS

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Education Requirements

• High School Diploma
• Preferred Associate's Degree in Science, Biopharmaceutical, Business, or relevant field

Required Skills

• Minimum of 1 years of relevant industry experience
• Demonstrated ability to work independently
• Demonstrated communication (written and verbal), collaboration, project management and data analysis skills
• Technical writing experience i.e. documentation of scientific data
• Demonstrated formal problem-solving e.g. fishbone, 5 whys

Preferred Skills

• Sterile Manufacturing/Production/Packaging shop floor experience highly preferred
• Working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical industry
• Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools
• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems, electronic batch record systems (PAS-X), and change control processes
• Experience managing against metrics and scorecards in a business environment
• Experience with presenting to an internal / regulatory auditor

#MSJR

Required Skills:
Accountability, Accountability, Analytical Problem Solving, Biopharmaceuticals, Biopharmaceutics, Change Management, Communication, Equipment Maintenance, Equipment Set Up, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices (GMP), Inventory Management, Machinery Operation, Maintenance Planning, Maintenance Planning Software, Management Process, Manufacturing Operations, Operations Management, Operations Support, Packaging Processes, Process Optimization, Production Planning, Production Scheduling, Project Management {+ 5 more}

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.--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".

The salary range for this role is
$71,900.00 - $113,200.00

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 .

You can apply for this role through (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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
03/14/2026
*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: R386967