Deviation Investigator Associate

Corden Pharma Colorado

About The Position

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being. Our People Vision We strive for excellence. We share our passion. Together, we make a difference in patients' lives. 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.

Requirements

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.
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.
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.
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.
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.)

Responsibilities

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

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