Summary
Overview
Work History
Education
Skills
Accomplishments
Interests
Timeline
Generic

Karen J. Loan-Hill

Townsend

Summary

To encompass past and present work and educational experience into a position with a strong team environment, where my input and work product will add to the success of the team as well as the company as a whole.

Experienced with team leadership, strategic planning, and operational management. Utilizes effective communication and organizational skills to drive project success. Track record of fostering productive work environments and achieving set goals.

Overview

15
15
years of professional experience

Work History

Manager, Quality Assurance Technical Operations

Bristol Myers Squibb
04.2022 - Current
  • Directs, coordinates and leads the facility quality assurance program to assist operations in assuring the production of quality products consistent with established Devens Standards and in compliance with regulatory and industry standards.
  • Direct experience supporting the manufacturing, testing, disposition, and distribution of CGMP products in the Manufacturing and Quality Organizations
  • Implementation and execution of Quality Systems
  • Leads and manages the day to day activities of quality assurance personnel and ensures the efficiency and effectiveness of on-site quality system activities. Directs quality "on the floor" support for Operations
  • Manages and coordinates all aspects of the lot disposition process. Ensures timely disposition of final drug product lots
  • Manages Material Review Board activities, Corrective and Preventive Action System, Document Review/Traceability Release function, Final Product Disposition, and Labels
  • Represents Quality Assurance on JuMP cross-functional teams participating in various operational programs such as FMEA development, Risk Management activities, Master Validation Planning and other continuous improvement activities
  • Reviews and Approves deviations / non-conformances. Establishes effective corrective action plans of all the Operations department non-conformances. Drive towards timely closure and effectiveness of deviations, CAPAs and Change Controls
  • Leads, supports, and participates with the Operations functions to proactively investigate, identify, and implement best-in-class quality manufacturing practices
  • Formulates and maintains quality assurance objectives complementary to corporate policies and goals
  • Manages QA personnel to meet JuMP QA objectives.
  • Ensures compliance with the Quality System Regulations, CGMP and industry standards
  • Writes/revises quality procedures or Work Instructions or other department operating procedures
  • Provides support to audits and regulatory inspections and ensures the execution of corrective action and compliance with internal quality procedures and external standards
  • Implementation and execution of Quality System.
  • Ensures compliance with the Quality System Regulations, CGMP and industry standards
  • Writes/revises quality procedures or Work Instructions or other department operating procedures
  • Provides support to audits and regulatory inspections and ensures the execution of corrective action and compliance with internal quality procedures and external standards
  • Managed and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Achieved departmental goals by developing and executing strategic plans and performance metrics.
  • Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
  • Led cross-functional teams to achieve project goals, fostering collaboration and innovation.
  • Facilitated team brainstorming sessions that led to innovative solutions for long-standing operational challenges.

Upstream Documentation Specialist

Bristol-Myers Squibb
01.2010 - Current
  • Responsible for all upstream batch record review and perform complete, comprehensive and compliant Batch Record Review where all issues are resolved before Field Quality performs review
  • Experience with Syncade, Delta V, Maximo, DCA, PI, SAP, Sample Manager and Trackwise software
  • Developed Batch Review spreadsheets to organize and keep track of each run and work with manufacturing to make sure that batch records are complete and comments are compliant with governing documents
  • Generate weekly updates on Upstream batch records and report to management and the disposition team the progress on review
  • Take the lead on working collaboratively with many different departments to build bridges and achieve common goals to keep the review process in line and within standard operating procedures as well as all governing documents
  • Work closely with operators to assist them in creating comments that are compliant
  • Created various process related reference only documents to assist with the process
  • Assist in audit readiness with regard to LSCC cleanliness and Batch Record Review
  • Keep up with on-the-floor training
  • Work closely with Field QA and the Manufacturing group to deliver timely batch record review on all Upstream records across all shifts
  • Drive continuous improvements for RFT batch records, minimizing/eliminating comments
  • Drives comment consistency
  • Create training materials such as CBT’s
  • Responsible for creating a batch record review team from shift operators and assist in training with QA for accurate and aligned review across shifts
  • Responsible for document related CAPA’s
  • Revised standard operating procedures
  • Track and manage periodic review of approved manufacturing procedures
  • Provide support to lead investigators during manufacturing investigations
  • Have well-developed knowledge of company procedures and policies and of information sources
  • Frequently interacts with area management, outside customers and functional peer groups across various departments
  • Works with Field QA and Manufacturing group to deliver timely batch record review across all shifts (both upstream and downstream)
  • Developed appropriate disposition metrics, works with manufacturing personnel to achieve said targets
  • Generates and reports on metrics on agreed frequency
  • Worked effectively with manufacturing group and Field QA groups to drive towards real-time review of batch records
  • Have driven continuous improvements for RFT batch records, minimizing/eliminating comments
  • Drives comment consistency
  • Have created training materials including CBT’s for SME input
  • Have worked with area SME to process PQC’s
  • Have been responsible for document related CAPA’s
  • I have revised standard operating procedures and have tracked and managed periodic review of approved manufacturing procedures
  • I provide support to lead investigator for manufacturing investigations
  • I have a well-developed knowledge of company procedures and policies and of information sources
  • I frequently interact with area management, outside customers and functional peer groups across various departments
  • I have 10 years of experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations
  • I possess excellent communication skills as well as proven written and verbal skills
  • Am a self-starter and capable of handling multiple priorities in a dynamic cross-functional team based environment
  • Am proficient in Microsoft Office applications including Word, Excel and PowerPoint
  • Have solid organizational and time management skills with the ability to prioritize activities in order to be consistent with departmental and site wide objectives
  • Ability to be flexible and quickly adapt to a changing work environment and schedules
  • Weekend, holiday and overtime may be required
  • Proficiency with Syncade and DeltaV a must
  • Experience with Trackwise, Maximo, and SAP required
  • Familiarity of all unit operations including Media, Buffer formulations, chromatography, TFF, BRX, cell separation, etc...) is preferred
  • Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability

Education

Mount Wachusett Community College
Devens, MA
03.2010

Bachelor of Science Degree - Paralegal Studies

Rivier College
Nashua, NH
01.1999

Skills

  • Customer service
  • Team leadership
  • Time management
  • Decision-making
  • Verbal and written communication
  • Complex Problem-solving
  • Staff training and development
  • Staff management
  • Goal setting
  • Documentation and reporting
  • Relationship building
  • Strategic planning
  • Project management
  • Cross-functional teamwork
  • Project planning
  • Policy implementation
  • Conflict resolution
  • Negotiation
  • Key performance indicators
  • Safety procedures
  • Employee onboarding
  • Coaching and mentoring
  • Work prioritization
  • Policy and procedure development
  • Data analysis
  • Risk management
  • Change management
  • Regulatory compliance
  • Trend analysis
  • Teamwork and collaboration
  • Computer skills
  • Effective communication
  • Problem resolution
  • Adaptability and flexibility
  • Positive attitude
  • Attention to detail
  • Multitasking
  • Problem-solving
  • Organizational skills
  • Work Planning and Prioritization
  • Good judgment
  • Process improvement
  • Active listening

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Documented and resolved [Issue] which led to [Results].
  • Achieved [Result] by completing [Task] with accuracy and efficiency.

Interests

  • Exploring famous landmarks, historical sites, and cultural attractions in a new destination
  • Historical Exploration
  • Documenting and sharing travel experiences
  • Adventure Travel
  • Road Trips
  • Exploring various forms of art, such as [activity 1], [activity 2], and [activity 3], to nurture creativity and personal growth
  • Crafting and DIY Projects
  • Interior Design
  • Creative Writing
  • Experimenting with different creative mediums, like [medium 1], [medium 2], and [medium 3], to expand skills and techniques

Timeline

Manager, Quality Assurance Technical Operations

Bristol Myers Squibb
04.2022 - Current

Upstream Documentation Specialist

Bristol-Myers Squibb
01.2010 - Current

Bachelor of Science Degree - Paralegal Studies

Rivier College

Mount Wachusett Community College

Similar Profiles

CREATE PROFILE