Corden Pharma - A Full-Service CDMO
QA Change Control & Deviation Specialist
Corden Pharma - A Full-Service CDMO, Boulder, Colorado, United States, 80301
Overview
QA Change Control & Deviation Specialist Corden Pharma - A Full-Service CDMO Provides support that facilitates seamless execution of the overall objectives of the Quality Department. Provides direct oversight of the Change Control Program. Partners with Operations on review of the Deviation Program. Supports the administration of Quality Assurance Documentation Programs, procedures, and controls ensuring that performance and quality of products conform to established Corden Pharma (CP) standards and federal regulations. Base pay range
$95,000.00/yr - $110,000.00/yr Location
Corden Pharma Colorado (CPC) Boulder, CO Responsibilities Change Control Management Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to manufacturing processes, equipment, documents, computerized systems, and other components Oversee the Change Review Board (CRB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans Collaborate with cross-functional teams, including Quality, Safety, and Manufacturing, to ensure change controls are well-documented, traceable, and compliant Product and Process Changes Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity Work closely with Operations Teams to implement changes and monitor post-implementation to confirm effectiveness and stability Training and Guidance Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization Provide training and mentorship to team members and departments on Change Control procedures, risk assessment, and compliance requirements Provide guidance from a Quality perspective on the Deviation Program Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities Able to react to change productively and handle other essential tasks as assigned
Leadership & Budget Responsibilities
Provides guidance and leadership where appropriate. Safety & Environmental Responsibilities
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. Quality Responsibilities
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), CPC manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPCs Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado. Qualifications Education and/or Experience
Bachelors Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical industry; or a combination of education and pharmaceutical industry experience.
Language Skills
Ability to read and comprehend instructions, communications, and the general intent of regulatory documentation. Ability to write instructions, communications, and general procedures. Ability to effectively communicate information in one-on-one and small group situations to Quality Department customers and vendors, regulatory authorities, and other employees of the organization. Ability to respond to common inquiries or complaints from customers, regulatory agencies, top management, and peers.
Mathematical Skills
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability
Ability to comprehend and carry out instructions furnished in written, oral, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to identify and address interpersonal issues in a professional business manner.
CERTIFICATES, LICENSES, REGISTRATIONS
None. PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific visual abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate. CORE COMPETENCIES
Knowledge of change control methodology Knowledge of cGMPs and Quality SOPs and Guidelines as they apply to documentation protocol and validation activities Strong knowledge of Q7 GMP for API and cGMP requirements Experience with electronic Quality Management Systems (eQMS), TrackWise strongly preferred Flexibility to organize and prioritize workload Excellent customer service skills, as well as effective interpersonal and conflict resolution skills Effective writing and editing skills; attention to detail is a must Proficiency in file and data organization and management Familiarity with manufacturing and regulatory issues pertinent to the pharmaceutical industry; particularly document control procedures
SALARY
Actual pay will be based on your skills and experience. Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service Accident Plan Critical Illness Insurance Dental Insurance Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance PPO/HSA Hospital Indemnity Plan ID Theft Protection Life Insurance Paid Parental Leave Tuition Reimbursement Wellness Program Vacation Three Weeks 1st Year Vision Insurance
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. #J-18808-Ljbffr
QA Change Control & Deviation Specialist Corden Pharma - A Full-Service CDMO Provides support that facilitates seamless execution of the overall objectives of the Quality Department. Provides direct oversight of the Change Control Program. Partners with Operations on review of the Deviation Program. Supports the administration of Quality Assurance Documentation Programs, procedures, and controls ensuring that performance and quality of products conform to established Corden Pharma (CP) standards and federal regulations. Base pay range
$95,000.00/yr - $110,000.00/yr Location
Corden Pharma Colorado (CPC) Boulder, CO Responsibilities Change Control Management Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to manufacturing processes, equipment, documents, computerized systems, and other components Oversee the Change Review Board (CRB) activities, ensuring thorough review and decision-making regarding change risks, impacts, and action plans Collaborate with cross-functional teams, including Quality, Safety, and Manufacturing, to ensure change controls are well-documented, traceable, and compliant Product and Process Changes Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity Work closely with Operations Teams to implement changes and monitor post-implementation to confirm effectiveness and stability Training and Guidance Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization Provide training and mentorship to team members and departments on Change Control procedures, risk assessment, and compliance requirements Provide guidance from a Quality perspective on the Deviation Program Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities Able to react to change productively and handle other essential tasks as assigned
Leadership & Budget Responsibilities
Provides guidance and leadership where appropriate. Safety & Environmental Responsibilities
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience. Quality Responsibilities
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), CPC manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPCs Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado. Qualifications Education and/or Experience
Bachelors Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical industry; or a combination of education and pharmaceutical industry experience.
Language Skills
Ability to read and comprehend instructions, communications, and the general intent of regulatory documentation. Ability to write instructions, communications, and general procedures. Ability to effectively communicate information in one-on-one and small group situations to Quality Department customers and vendors, regulatory authorities, and other employees of the organization. Ability to respond to common inquiries or complaints from customers, regulatory agencies, top management, and peers.
Mathematical Skills
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability
Ability to comprehend and carry out instructions furnished in written, oral, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to identify and address interpersonal issues in a professional business manner.
CERTIFICATES, LICENSES, REGISTRATIONS
None. PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific visual abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate. CORE COMPETENCIES
Knowledge of change control methodology Knowledge of cGMPs and Quality SOPs and Guidelines as they apply to documentation protocol and validation activities Strong knowledge of Q7 GMP for API and cGMP requirements Experience with electronic Quality Management Systems (eQMS), TrackWise strongly preferred Flexibility to organize and prioritize workload Excellent customer service skills, as well as effective interpersonal and conflict resolution skills Effective writing and editing skills; attention to detail is a must Proficiency in file and data organization and management Familiarity with manufacturing and regulatory issues pertinent to the pharmaceutical industry; particularly document control procedures
SALARY
Actual pay will be based on your skills and experience. Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service Accident Plan Critical Illness Insurance Dental Insurance Disability Insurance Employee Assistance Program Flexible Spending Account Health Insurance PPO/HSA Hospital Indemnity Plan ID Theft Protection Life Insurance Paid Parental Leave Tuition Reimbursement Wellness Program Vacation Three Weeks 1st Year Vision Insurance
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. #J-18808-Ljbffr