Quality Control Analyst III

Quality Control Analyst III

Reports to: Varies Department: Quality FLSA status: Exempt

Position overview

The Quality Control Analyst 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.

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.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

1. Perform complex testing and data evaluation
2. Perform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
3. Participate in or assist with test method validations
4. Evaluate data for trends
5. Support supervisors in OOS Investigations and complete CAPA requirements
6. Interact with outside departments including attending meetings, providing updates, etc.
7. Coordinate testing performed at outside testing labs, raw materials, etc.
8. Maintain a detailed and accurate recording of activities and results on paperwork 
9. Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause tools
10. Train upon and understand methods, equipment and standard operating procedures
11. 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
12. Support equipment upkeep
13. Prepare and order supplies, as necessary
14. Enter data into relevant data management systems. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
15. Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
16. Interact with other departments within the company for testing needs and scheduling
17. May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
18. May lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability results

Education, experience, certification and licensures Required

·         Bachelor's degree in Chemistry or related field

·         Minimum 5-7 year’s pharmaceutical experience or equivalent combination of education and experience

Preferred

·         Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

1. 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
2. Ability to meet deadlines and work under pressure with limited supervision
3. Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently 
4. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations 
5. Ability to write reports, business correspondence, and procedure manuals
6. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
7. 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
8. Ability to define problems, collect data, establish facts, and draw valid conclusions
9. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
10. Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
11. Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Pay range: $70,000-91,000 /year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

All interested applicants must apply online.  Curia is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Salary : $70,000 - $0