Quality Control Analyst III Job Rensselaer New York USA,Quality Assurance

Location: Rensselaer

Quality Control Analyst III in Rensselaer, NY - Days

Build your future at Curia, where our work has the power to save lives

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 (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
And more!

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.

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 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

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

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

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential…