Job Description

POSITION OVERVIEW

The Associate Specialist, Document Control is responsible for the administration of the Document Management System at the Wilson Site. This position also provides general and GMP-specific clerical responsibilities that vary in scope.

The Associate Specialist, Document Control will report to the Associate Director, Quality COE.

PRIMARY ACTIVITIES

Document Archivist

• Responsible for Retrieval and tracking of Site Batch Records. This includes but not limited to retrieval from operations, archiving into the appropriate tracking system, scanning for Canadian Market, and finally filing in Document Retention room.

• Responsible for the tracking, retrieval, storage (including shipping offsite), retrieval challenge, and destruction of batch records beyond retention period as applicable managed in the Document retention room.

• Ensure proper allocation of Retention room capacity.

Controlled Print Activities

• Responsible for managing and executing controlled print requests for the site and laboratory.

• Responsible for the reconciliation of any High/Medium controlled print documents

• May require emergency requests during second, third shift, or weekends.

• Maintain/order printing supplies as needed.

Standard Operating Procedure management core responsibilities

Global Shared Services manages the site SOP Management program, but, in the event of an expedited request:

• Manage the Quality Docs DCC workflow process including but not limited to, creating the DCC, routing for review/approval, linking the draft.

The site will be responsible for the following:

• Manage SOP 3-year review notifications for SOPs and Flowcharts

• Complete requests for previous versions of a Quality Docs SOP/WI/Job Aid/Template

Competencies/Leadership Behaviors/Skills:

• Excellent typing skills - formatting, spelling, etc.

• Ability to coordinate, log, track, and follow-up on outstanding items

• Self-motivated with a strong sense of urgency to meet timing requirements

• Work must be accurate and properly documented for GMP purposes

• Must be able to manage multiple tasks day to day

• Ability to achieve objectives requiring a high level of cooperation from others throughout the organization

• Must be able to prioritize tasks based on deadlines and schedule changes

Employees are expected to perform other duties or to accept other assignments to compensate for workload shifts as the need arises in addition to the major responsibilities listed above

SKILLS

Education Requirement:

• High School Diploma

Required Skills

• Functional experience in data or document management

• Excellent office software proficiency (MS Word, MS Excel, Visio, and Adobe Acrobat)

Preferred Skill

• Quality Management systems, cGMP, and regulatory inspections

• Excellent technical writing skills

• Detailed Oriented

• Learning and Development

• Project Management

• Problem Solving

#MSJR

VETJOBS

Current Employees apply HERE

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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".

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

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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:

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Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R330305