Process and Procedural Document Specialist Job at Parexel

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Notary Processing and Support Specialist

The Notary Processing and Support Specialist is responsible for providing except...

Location

United States , Orlando

Salary:

39000.00 - 40000.00 USD / Year

Certus

Expiration Date

Until further notice

Requirements

Proven experience using Microsoft Office Suite including Excel, Word, Outlook and Power Point
Excellent active listening skills with a positive attitude, energy, and demeanor
Reliable individuals that can always be counted on to give their best work and follow tasks through completion
Steady, even pace to promote accuracy and quality of work
Self-starter comfortable taking initiative and assist finding solutions to problems that may arise in the manufacturing of products
Ability to complete set of procedures and tasks completed before new ones are begun
Work with established systems, standards, and procedures
Good organizational skills and attention to detail
Helpful, supportive communication with management and peers
Excellent customer service skills

Job Responsibility

Responsible for handling and responding to issues such as application status, complaints, refunds, among other as the SME for the state or group of states assigned
Respond to inbound calls outside the assigned state effectively and add clear notes in the applicant’s memo section
Responsible for all data entry for their state(s) to include complete, accurate, entry of the client’s data into in house system, follow up of applications received, correcting upper/lowercase issues before submitting applications and rejecting incomplete applications, as well as follow up with client to correct
Responsible for submitting the applications of their state(s) “to the state” within three days of their arrival at ASCID to include incomplete or special circumstance applications
The PSS will be responsible for establishing and maintaining a friendly, business-like relationship with each of the state employees in the states they represent
The PSS is also responsible to report to the Sr. Vice President Insurance Division, “problem” situations that arise with any client and provide clear documentation in the client’s account so that any PSS or SVP can address complaints effectively
Perform additional duties where needed

Fulltime

Specialist Manufacturing: NPI, Upstream Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

New

Process and Procedural Document Specialist, Sr. Manager

Parexel FSP is hiring a Process and Procedural Document Specialist, Sr. Manager ...

Location

Argentina; Brazil; Mexico , Remote; Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A minimum of a BA or BS is required, advanced degree in relevant field desirable. Degree or professional certification in process design or change management, or equivalent experience
A minimum 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical). Demonstrated process development expertise
Ability to manage multi-phase moderately complex projects with multiple contributors/collaborators, facilitate cross functional global or enterprise teams, optimize subject matter involvement, and interacts at all levels in a matrix environment. Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
strong planning and multi-tasking skills
Ability to lead by example, demonstrating the sponsor’ values and effectively implement strategies through influence and persuasion
Demonstrate ability to adapt to changing situations and work well under pressure
Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project)
tools for process design and mapping
and systems for document management, publishing, communication, and learning management
Understanding of the fundamentals of electronic publishing of procedural documents

Job Responsibility

Lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, with minimal assistance, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for approximately 10,000 colleagues across the sponsor’ clinical, medical, safety, regulatory and enterprise quality management system global processes
Function as a key subject matter expert in the document management model, quality management system, and quality standards. Providing advice and recommendations to global and local colleagues on process enhancement and continuous improvement project teams. provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles
Plan and manage process development projects to address the full life cycle: requirements and policy setting
process design, documentation and training development and delivery
change management planning and deployment
and transition to an oversight system that incorporates performance monitoring and continuous improvement once the new/revised process is fully operational
Applies knowledge and understanding of global regulations in a GxP environment and produces processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind and contains measurable controls where applicable
Identifies areas of training focus and collaborate closely with training developers on training strategies and plans
Contribute to compliance and audit/inspection readiness strategies and plans
Participate in regulatory inspections, external PV license partner audits, and other internal audits by being the liaison for documentation requests and responding to findings

Records Management Specialist

This position is responsible for responding to inquiries and processing applicat...

Location

United States , Landover, MD

Salary:

Not provided

PN Automation, Inc

Expiration Date

Until further notice

Requirements

High School Diploma
BS degree preferred
Three (3) years related experience with two (2) years direct experience processing documents and at least one (1) year of office, records, or computer experience
Technical background with knowledge of folder structure systems for electronic documents
Proficient with office automation tools such as Microsoft Office and other common desktop applications
Must have a combination of excellent analytical skills and attention to detail
Possess excellent verbal and written communication skills
Ability to lift and move standard boxes (35 lbs.)
Must be able to work in a fast-paced paper and electronic production environment
Requires ability to bend and stretch to reach files, and push a fully loaded mail cart

Job Responsibility

Process paper and electronic documents in accordance with current SOP's
Selection of appropriate method from a wide variety of procedures or simple interpretations of a limited number of SOP's
Understanding multiple data entry systems
Selection and identification of relevant data, labeling, jackets, logging, assignments and all associated data entry with a high level of accuracy
Perform data entry functions, as needed
Redact patient and/or manufacturer data

Fulltime

Clinical Documentation Coordinator

We are looking for a Clinical Documentation Coordinator for full-time permanent ...

Location

United States , Las Vegas

Salary:

39.00 - 60.00 USD / Hour

Dynamic Computing Services

Expiration Date

Until further notice

Requirements

Valid license by the State of Nevada to practice as a Registered Nurse and one of the following, Certified Clinical Documentation Specialist (CCDS), Certified Clinical Documentation Specialist-Outpatient (CCDS-O) or Certified Document Improvement Practitioner (CDIP)
An international medical graduate degree and one of the following: Certified Document Improvement Practitioner (CDIP), Certified Clinical Documentation Specialist (CCDS), Certified Clinical Documentation Specialist-Outpatient (CCDS-O)
Certification in one of the following: Certified Coding Specialist (CCS), Registered Health Information Technician (RHIT), or Registered Health Information Administrator (RHIA), issued by the American Health Information Management Association, Certified Professional Coder (CPC), Certified Professional Coder-Physician-based (CPC-P), AND one of the following: Certified Document Improvement Practitioner (CDIP), Certified Clinical Documentation Specialist (CCDS), Certified Clinical Documentation Specialist-Outpatient (CCDS-O)
Knowledge of: Medicare reimbursement system and coding structures
hospital policies and procedures
Joint Commission Accredited Health care Organizations standards, state statutes governing hospital services and health care, Medicare/Medicaid guidelines and other relevant regulations and standards
clinical medical and nursing procedures
disease processes
department and hospital safety practices and principles
patient rights

Job Responsibility

Responsible for improving the overall quality and completeness of clinical documentation
Facilitates modifications to clinical documentation through extensive interactions with physicians, nursing staff, other members of the health care team and Health Information Management (HIM) coding staff to ensure that appropriate reimbursement and clinical severity is captured for the level of service rendered to all patients with a DRG based payer

Fulltime

Junior P&C Services Specialist

Junior P&C Services Specialist role in the GBO Knowledge Management Team support...

Location

Poland , Poznań

Salary:

Not provided

IKEA

Expiration Date

Until further notice

Requirements

Bachelor's degree or finishing studies soon
Background in HR, payroll or foreign language philology (appreciated but not mandatory)
Proficiency in English
Knowledge of other foreign languages will be an asset
Open to challenges and work in variable/changing environment
Love learning new things and taking initiative
Enjoy self-development
Would like to improve skills in MS Office
Excellent written communication skills in English
Strong attention to detail and ability to simplify complex information

Job Responsibility

Develop work instructions, system procedures and other supporting documents
Translate operational processes into clear, accessible language
Collaborate with Subject Matter Experts to gather and validate content
Regularly review and update documentation based on Change Requests
Monitor feedback from users to improve clarity and usability
Ensure all documentation complies with internal standards and formatting guidelines
Organize and manage documentation repositories
Act as a point of contact for documentation-related inquiries

What we offer

Remote/hybrid working model
Fantastic office with IKEA furniture
Free underground parking with electric charger and bicycle parking
Stable employment
Flexible working hours
Annual appreciation bonus
Home work allowance
Cafeteria system
Tack! loyalty program
Private medical care

Quality Document Control Specialist

This position is responsible for the creation and processing of all change reque...

Location

United States , Tempe

Salary:

28.00 - 35.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Quality Management Systems experience
Document Controls experience
Medical device industry experience
Highschool diploma and at least 1+ year experience in documentation related position
Basic understanding of regulations
Advanced language proficiency in reading, writing, understanding, and communicating in English
Attention to detail
Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
Intermediate organizational and administrative skills
Experience in working in a cross-functional team environment as well as the ability to function independently

Job Responsibility

Creation and processing of all change request packets
Creation of controlled documents
Tracking of packets and all associated paperwork
Participation as an active team member in cross functional teams and ownership of project team documentation
Origination, editing and revision of technical documentation
Assist with the migration between two different MasterControl systems
Participates in regulatory compliance audits and inspections
Participates in investigations
Completes applicable job-specific training
Effectively manage the end-to-end change lifecycle and identify process improvements where possible

Fulltime

Process and Procedural Document Specialist

Parexel

Location:
Poland

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 16, 2026

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