Deviation Investigator Associate

Corden Pharma - A Full-Service CDMO• Boulder, CO, US, CO

6d•$76,500 - $95,500

About The Position

Responsible for the timely completion and writing of deviations, laboratory investigations, and assigned corrective or preventive actions. The associate can lead manufacturing or laboratory investigations with minimal guidance and works with supervisors, operators, technical teams, and other staff to collect data for root cause analysis and CAPA identification. The position also participates in the Operational Excellence Program and performs investigations in compliance with applicable CordenPharma procedures and cGMP requirements.

Requirements

Bachelor’s degree in a technical field such as Engineering, Chemistry, or Science, and two years of pharmaceutical manufacturing experience in technical support, or an equivalent combination of education and experience.
Ability to read, analyze, and interpret procedures, technical data, and governmental regulations.
Ability to write reports, business correspondence, procedures, and technical documents; present information and respond to questions from employees, managers, customers, and regulatory auditors.
Ability to speak, read, and write in English.
Ability to apply mathematical operations and analytical techniques, including frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret technical instructions in mathematical or diagram form and handle abstract and concrete variables.
Technical writing skills, including translating complex scientific or technical information into brief, complete reports for educated readers who may not be specialists.
Ability to work effectively in cross-functional teams and troubleshoot and solve problems.
Logic, decision-making, and critical-thinking skills.
Strong typing and computer skills, including proficiency with Microsoft Office Suite (Word, Excel, and PowerPoint), and familiarity with cGMP quality systems.
Ability to manage multiple ongoing projects concurrently and work in a fast-paced environment.
Meeting facilitation, conflict resolution, and strong written and verbal communication skills.
Knowledge of common investigation tools such as 6M and 5 Whys.
Ability to perform duties in a cGMP environment and familiarity with cGMP quality systems.
Ability to meet the physical demands of the role, including occasionally lifting or moving up to 50 pounds.

Responsibilities

Initiate, complete, draft, and close assigned investigations on time.
Work with cross-functional teams to collect data and conduct interviews promptly after a deviation, including documenting deviation impact with technical teams.
Lead and perform root cause analysis to determine the most likely root cause or contributing factors for deviations.
Gather and interpret data and document the impact of deviations on in-scope materials, products, or systems.
Facilitate or participate in meetings to align review teams and subject matter experts on investigation plans.
Identify and communicate observed trends to support effective and sustainable process improvements.
Progress multiple projects and deviations simultaneously.
Collaborate internally and with customers to resolve corrections to deviation drafts.
Participate in the Corden Operational Excellence Program to drive continuous improvement.
Collaborate on or update procedures and documentation to address identified CAPAs.
Conduct investigations in compliance with applicable CordenPharma procedures.
Provide guidance and leadership based on deviation results, lead assigned investigations, and pursue identified process improvements.

Benefits

401(k) matching: employer contributes 100% of the first 6%, fully vested after two 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 and paternity leave.
Tuition reimbursement.
Wellness program.
Three weeks of vacation in the first year.
Vision insurance.