Quality Control Analyst

Job Title - Quality Control Analyst 1
100% ONSITE


Primary Duties:


Execute routine in-process, drug substance, and stability test methods.
Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).
Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).

Responsibilities: Job Function and Description:
Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOPs).
Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.
Complete all testing, including special project and protocol testing in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
Support low risk deviations, CAPAs and change controls within the electronic Quality Management System.
Initiate and own laboratory investigations.
Occasionally participate in department problem-solving.
Author minor revisions to existing SOPs.
Receives general instructions on routine work and detailed instructions on new assignments.
May be required to work overtime or be assigned to a different shift as needed.
May perform equipment maintenance and calibrations as required.
Complete mandatory training within required timeframe.
Perform other duties as assigned.


Education and Experience Requirements
Bachelors or masters degree in any Life Sciences with relevant laboratory coursework.
0-3 years of relevant experience.
Previous experience in a regulated environment preferred.
Laboratory instrumentation understanding or experience preferred.
Must be able to communicate effectively with managers and peers.
Must be able to read, write, and converse in English.
Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service. Good interpersonal skills and able to work effectively and efficiently in a team environment.
Knowledge of cGMP manufacturing preferred.
Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.
Must display eagerness to learn and continuously improve.


Key Skills, Abilities, and Competencies:
QC Analytical Skill Set HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, Client, Osmolality, TOC, strong micropipetting skills
QC Bioassay Skill Set ELISAs, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinets
QC Micro Skill Set Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems


Complexity and Problem Solving
Employee at this level is involved in routine tasks of basic scope and complexity.
Employee receives detailed instructions on new work and refers to policies and procedures for guidance.
Responsible for conducting independent work with guidance from trainers and more senior staff.
Responsible for making basic decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.
Understand the needs of key collaborators (i.e., Quality and Manufacturing Operations) to provide compliant and timely test results.


Internal and External Contacts:


Participate in cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology).


Other Job Requirements
Physical Demands:
Stand or sit -? Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment.


In certain areas of Quality Control, the following may apply:
Carry weight, lifting - Frequently moves laboratory materials and portable instruments weighing up to 30 pounds.
Climb - Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples.
Dexterity/balance required to gown for cleanroom work, balance and dexterity are required.


Other / Travel Requirements:
May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.
Willingness to travel to various meetings or training, this could include overnight trips.
Requires 0-5% travel.