Quality Control Analyst I, II or III

Curia•Springfield, MO

14d

About The Position

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!

Requirements

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
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 independently
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
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
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
Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600)

Nice To Haves

Experience working in cGMP or GLP pharmaceutical industry environment
ISO 9001 and 13485 a plus

Responsibilities

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.