Quality Control Analyst I, II or III

The Quality Control Analyst I, II or III is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples. This role may be filled as a Quality Control Analyst I, II, or III depending on level of education and experience.

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.

This is a Salary Non -Exempt Role (eligible for payment of overtime in accordance with Fair Labor Standards Act)

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit options 
• Paid training, vacation and holidays 
• Career advancement opportunities 
• Education reimbursement
• 401k program
• And more! 

Essential job duties

• Perform complex testing and data evaluation such as TGA
• Perform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
• Participate in or assist with test method validations
• Evaluate data for trends
• Support supervisors in OOS Investigations and complete CAPA requirements
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at outside testing labs, raw materials, etc.
• Maintain a detailed and accurate recording of activities and results on paperwork 
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause tools
• Train upon and understand methods, equipment and standard operating procedures
• Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
• Support equipment upkeep
• Prepare and order supplies, as necessary
• Enter data into relevant data management systems. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Interact with other departments within the company for testing needs and scheduling
• May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
• May lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability results

Good Manufacturing Practices & Good Documentation Practices (GMP & GDP)

• Perform all GMP related documentation in compliance with ALCOA and good documentation practices as defined by site SOP’s.
• Strict compliance with all cGMP documents

SOP’s, Batch records, protocols, change controls, controlled forms, etc. 

• Ensure all cGMP applicable training is kept current

Do not perform any cGMP task for which have not received appropriate training

• Escalate any cGMP concerns to Supervisors and to Quality Department as needed
• Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices. 

Education, experience, certification and licensures

Required

Bachelor's degree in Chemistry or related field

QC Analyst I: 0-2 Year's Experience

QC Analyst II: 3-5 Year's Experience

QC Analyst III: 5-7 Year's Experience 

Preferred

Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to meet deadlines and work under pressure with limited supervision
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects