Quality Control Analyst

Siegfried•Grafton, WI

2d•Onsite

About The Position

The Quality Control Analyst I is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. Siegfried is a trusted and respected partner to the pharmaceutical industry, upholding the highest standards in safety, quality and sustainability, while fostering a culture that empowers employees to thrive. It is a rapidly expanding global company where diverse perspectives and experiences come together in a collaborative environment, valuing both collective success and individual contributions, offering long-term opportunities to grow and make an impact.

Requirements

Bachelor’s degree in chemistry or related field
Minimum 0-3 years’ 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, 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
Regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear.
Frequently required to reach with hands and arms.
Often required to climb or balance; and stoop, kneel, crouch, or crawl.
Occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, and ability to adjust focus.
Potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).
Occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required).
Employee will be responsible for generating hazardous waste for treatment, storage and disposal.
Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act.
Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

Nice To Haves

Experience in a cGMP or GLP pharmaceutical industry environment

Responsibilities

Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
Perform chromatography (Liquid/GC) after extensive qualification and training
Perform wet chemistry assays
Regularly perform water sample collection
Back up for QC analytical instrument maintenance and calibration
Performance of QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
Assist in the review of QC data and provide summaries to management as needed
Assist QC Management, as needed, in the completion of OOS, deviations and CAPAs investigations for QC
Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure.