Quality Control Analyst II

Lake Pharma•Rensselaer, NY

34d•$63,000 - $79,000

About The Position

QC Analyst II in Rensselaer, NY The Quality Control Analyst II is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. 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
Minimum 3-5 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 and review data
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