Principal Specialist Job Description

Principal Specialist Job Description

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Principal specialist provides quality oversight of projects including: Equipment Qualification, Method Validation, Aseptic process validation, Process Validation, Work Order Review, Cleaning and Sterilization Validation, Shipping Validation, Regulatory Submissions, and Contract Manufacturing.

Principal Specialist Duties & Responsibilities

To write an effective principal specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included principal specialist job description templates that you can modify and use.

Sample responsibilities for this position include:

Facilitate annual process walkthroughs and ensure that process and control documentation is updated appropriately
Perform financial statement and process-level risk assessments to determine the optimal control mix for the Sarbanes Oxley Program within assigned area of focus
Participate in the semi-annual SOX scoping process
Develop a high degree of subject matter knowledge in Financial Statement processes and controls in assigned areas, to enable effective challenge of control design
Monitor and assess the impact of business process changes on the control environment in assigned areas, identify new risk areas and ensure that controls are added or changed to ensure continued risk mitigation
Partner with business units, IT and control owners to provide guidance around compliance and implementation of controls
Participate in control testing activities as needed, including performing test procedures and/or reviewing results of control testing
Experience performing process, risk, and controls assessments for IT-related processes
Experience with identifying and assessing the design and operating effectiveness of IT Controls, including IT General Controls, System Development Life-Cycle controls, and application and interface controls
Oversee the month end close and quarter end reporting responsibilities to ensure they are completed accurately and timely

Principal Specialist Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Principal Specialist

List any licenses or certifications required by the position: NCMA, CISSP, IAM, IAT, PMP, TOGAF, GSLC, CISA, CASP, CISM

Education for Principal Specialist

Typically a job would require a certain level of education.

Employers hiring for the principal specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Education, Business, Computer Science, Technical, Business/Administration, MBA, Management, Military, Information Technology

Skills for Principal Specialist

Desired skills for principal specialist include:

Applicable local
State/province
Federal/national statutes and guidelines
Validation Lifecycle Approach
Relevant regulations and guidances in order to act as a resource for colleagues
Process improvement concepts and applications in compliance environment
Bulk manufacturing process and drug production aseptic filling process and associated regulatory requirements
GMP Pharmaceutical manufacturing
GMP guidelines
ICH Q7

Desired experience for principal specialist includes:

Bachelor's Degree in Accounting, Finance, or Risk Management related discipline
CPA licensure and/or CIA certification
Previous SOX or other internal control program experience, preferably in a Financial Institution setting
Prior public accounting or internal/external auditing experience
Lead monthly and quarterly analytics for income statement and balance sheet accounts performed by team
Perform analysis on root cause issues and recommend solutions

Principal Specialist Examples

1

Principal Specialist Job Description

Job Description Example
Our company is hiring for a principal specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for principal specialist
  • Facilitate the consistent use of best practices for compliance, accuracy, completeness, documentation, timeliness and other relevant measures of quality
  • Partner with both internal and external groups to understand accounting policies and implications to home loans accounting processes
  • Collaborate with different teams within home loans accounting and across the organization on various planned and ad-hoc corporate initiatives
  • Represent SRO on a cross-functional agile project team
  • Perform test execution
  • Perform training with impacted SRO teams
  • Prepare balance sheet account reconciliations as needed
  • Identifying and determining applicability of risks
  • Designing, implementing and monitoring compliance controls
  • Proactive identification, assessment and monitoring of potential risks inherent to the Stress Testing process
Qualifications for principal specialist
  • 3 years of accounting, financial reporting or audit experience
  • Strong knowledge of PeopleSoft general ledger and/or Hyperion Financial Management
  • Bachelor’s Degree in accounting, finance or business related field, or military experience
  • 2 years Retail Bank / Financial Services experience
  • ReconPlus application experience
  • MS Office software experience – Excel, PowerPoint
2

Principal Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of principal specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for principal specialist
  • Executing Compliance Advisor tasks outlined in the Compliance Management
  • Coordinates the work of others within the team and in the site
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
  • Ensure supply of high quality product through implementation and oversight of the Quality Management System for the site
  • Champions Permanent Inspection Readiness (PIR) and Quality and Compliance Excellence (QCE) programs
  • Strong experience of intrusions analysis and incident response
  • Expert level host and network based forensics skills
  • Expert level log analysis and correlation skills
  • APT campaign/Intrusion Set analysis and tracking experience
  • Strong Unix/Linux command line experience
Qualifications for principal specialist
  • Bachelor’s Degree in accounting, finance or business, or military experience
  • Agile team methodology
  • JD Degree or military experience
  • 2 years experience with litigation, negotiations or contracts
  • Self-starter with ability to work independently under high pressure situations
  • At least 2 years of experience in compliance, legal, or audit or performing regulatory compliance assessments
3

Principal Specialist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a principal specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for principal specialist
  • Strong understanding of Windows & Linux operating systems
  • Experience with SIEMs QRadar, ArcSight
  • Knowledge of industry best practices for foundational security elements, including network device and system-level hardening
  • Ability to assess security incidents quickly and effectively and communicate a course of action to respond to the security incident while mitigating risk and limiting the operational and reputational impact to EA
  • Specific responsibilities will include reactive power rate cases, firm transportation rates, assisting in “Grid 2.0” rate proceedings on topics such as net metering policy, distributed energy resources, utility tax treatment of renewables, and other topics as assigned
  • Management and execution of the site business processes for the quality systems
  • Maintain compliance requirements for established quality systems programs
  • Accountable for site level execution and performance of the Quality System
  • Expertise in metrics and trending
  • Provide Change Control Coordinator and Quality Assurance support to GMQO-Bio Change control process
Qualifications for principal specialist
  • At least 1 year of experience supporting, partnering and interacting with internal business clients
  • At least 1 year of experience in Influencing changes to existing practices for the purpose of mitigating compliance risk
  • CRCM - Certified Regulatory Compliance Manager
  • 2 years of experience in Regulatory compliance assessment - assess scenarios for the purpose of verifying regulatory adherence
  • 2 years of experience in Direction setting for internal resources via indirect reporting relationships
  • Bachelor’s Degree in accounting or related field, or military experience
4

Principal Specialist Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of principal specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for principal specialist
  • Perform review of results to audit process or equipment compliance to FDA and GMP requirements
  • Help remediate processes and systems in accordance with company standards and regulatory requirements
  • Demonstrate understanding of 21 CFR Part 11, 210, 211 and equivalent global regulations
  • Interact with project teams and applicable research groups as they impact the quality operation
  • QA project management
  • Interpret complex, explicit documentation for new and current compliance procedures and FDA enforcement action/trends
  • Provide guidance to End User for their SOPs
  • Development and administration activities for complex Request For Information (RFI), Request for Proposals (RFP) and Request for Quotes (RFQ)
  • Qualifying and selecting complex suppliers and seeking alternate suppliers
  • Perform Cost Analysis and Price Analysis and assist team members
Qualifications for principal specialist
  • 3 years of accounting or audit experience
  • 3 years of experience in financial systems
  • Demonstrated ability to co-ordinate the work of others, leading project teams
  • Demonstrated ability to clarify, communicate and solve complex problems
  • Respond to emerging threats such as APT and other forms of targeted attacks, organized crime
  • Perform detailed forensic analysis of assets, including logs, malware samples, hard drive images
5

Principal Specialist Job Description

Job Description Example
Our company is looking to fill the role of principal specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for principal specialist
  • Provides leadership to the team and manage in different environments
  • Schedule, plan, and prepare for external supplier and contractor audits on behalf of BI pharmaceutical world functions, including Operations, Development, Biopharma and Animal Health, internal audits of BIVI and other BI operating units Operations, Development, Biopharma and Animal Health divisions
  • Lead and conduct audits of external suppliers and contractors on behalf of the BIV-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health
  • Create and issue the audit report for each audit to submit to BIVI management as a means to ensure SOP(s), facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA, USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external
  • Perform follow-up actions and oversee investigations of compliance issues noted during audits and inspections or otherwise observed or reported
  • Perform follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported
  • Resolve quality concerns and implement quality improvements by meeting with other department Managers, Staff Managers to assure current methods, procedures or SOP’s meet current standards
  • Mentor and train other BI auditors regarding auditing skills and current and future quality and regulatory trends as part of BI global supplier auditor training
  • Enable global quality overview of BI suppliers, challenge their status and identify gaps/risks for BI's Supply Chain Integrity
  • Functions as trainer for Quality Specialists and provides mentoring in collaboration with the Head of Standards & Processes Governance
Qualifications for principal specialist
  • Perform malware analysis and other attack analysis to extract indicators of compromise
  • Implement and manage tools and technologies for indicators of compromise and other threat intelligence
  • Communicate status of response, resolution and final root cause analysis to the appropriate stakeholders on a regular basis
  • Ensure that, where appropriate, all forensic investigations are recorded and tracked to meet audit and legal requirements
  • Mentor and train more junior analysts in intrusions and intelligence-driven network defense techniques and skills
  • Communicate effectively with representatives of EA business units, technology specialists, and vendors

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