Quality Control Analyst III

Curia • Town of East Greenbush, NY

17h • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Chemistry or related field
• Minimum 5-7 year’s pharmaceutical experience or equivalent combination of education and 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); ISO 9001 and 13485 a plus

Nice To Haves

• Experience working in cGMP or GLP pharmaceutical industry environment

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 and laboratory method trouble shooting
• Provide technical assistance during the shift for test method trouble shooting
• 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

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level