What are the responsibilities and job description for the Deviation Investigator Associate position at Corden Pharma - A Full-Service CDMO?
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.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
Summary
Responsible for on time completion and writing of deviations, laboratory investigations, and/or assigned corrective/preventative actions. Can lead manufacturing or laboratory investigations with minimal guidance. Works directly with supervisors, operators, or other Corden staff to collect data to support root cause analysis and CAPA identification. Participates in Operational Excellence Program.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
Provides guidance and leadership where appropriate, based upon the results of deviations. Leads efforts for investigations assigned and process improvements identified.
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), Corden Pharma Colorado 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. CPC’s 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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCE
Bachelor’s Degree (BS) from a college or university in a technical field (Engineering, Chemistry, Science); and 2 years Pharmaceutical Manufacturing experience in a technical support; or equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret procedures, technical data, and governmental regulations. Ability to write reports, business correspondence, and procedures/technical documents. Ability to effectively present information and respond to questions from other employees, managers, customers, and regulatory auditors. Ability to speak, read and write in English.
Mathematical Skills
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
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 vision abilities required by this job include close vision, distance vision, color 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 occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
Actual pay will be based on your skills and experience.
Benefits
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.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
Summary
Responsible for on time completion and writing of deviations, laboratory investigations, and/or assigned corrective/preventative actions. Can lead manufacturing or laboratory investigations with minimal guidance. Works directly with supervisors, operators, or other Corden staff to collect data to support root cause analysis and CAPA identification. Participates in Operational Excellence Program.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.
- Responsible for initiation, completion, drafting, and on time closure of investigations assigned
- Work closely with cross functional teams to collect data and conduct interviews immediately following a deviation; including working with technical teams to identify and document deviation impact
- Lead and perform root cause analysis to determine most likely root cause/ contributing factors for a deviation
- Gather and interpret data to ensure the deviation includes a documented justification for impact on materials, product, or system within scope of the deviation
- Facilitation and/or participation in meetings to drive internal alignment between the review team/area subject matter expert(s) on an investigational path forward
- Identification and communication of observed trends to drive effective and sustainable system process improvements
- Able to progress multiple projects and deviations simultaneously
- Collaborate internally and with customers for correction resolution on deviation drafts
- Participation in the Corden Operational Excellence Program to drive continuous improvement
- Collaborate and/or update procedures/documentation to address identified CAPAs
- Perform investigation in compliance with applicable CordenPharma procedures
Provides guidance and leadership where appropriate, based upon the results of deviations. Leads efforts for investigations assigned and process improvements identified.
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), Corden Pharma Colorado 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. CPC’s 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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCE
Bachelor’s Degree (BS) from a college or university in a technical field (Engineering, Chemistry, Science); and 2 years Pharmaceutical Manufacturing experience in a technical support; or equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret procedures, technical data, and governmental regulations. Ability to write reports, business correspondence, and procedures/technical documents. Ability to effectively present information and respond to questions from other employees, managers, customers, and regulatory auditors. Ability to speak, read and write in English.
Mathematical Skills
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
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 vision abilities required by this job include close vision, distance vision, color 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 occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Technical writing for the educated, but uninformed reader. Able to translate very complex and challenging scientific or technical information into a brief and complete report
- Work well on a team and be able to trouble shoot and problem solve in a cross functional team setting
- Proven logic and decision-making abilities, critical thinking skills
- Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with cGMP Quality Systems
- Investigator/initiators are expected to work in a Good Manufacturing Practice (cGMP) environment and have familiarity with cGMP quality systems
- The ability to manage multiple ongoing projects concurrently
- Have excellent meeting facilitation and conflict resolution skills
- Professional and proficient technical writing capability
- Ability to work in a fast-paced environment
- Strong written and verbal communication skills are required
- Knowledge of common investigative tools (6M, 5Whys, etc.)
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 Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
Salary : $65,087 - $83,181
