DUTIES.
Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner.
Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA).
* Own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).
Primary Duties
Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner.
Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA).
Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).
Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.
Own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).
Responsibilities: Job Function and Description
Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOP's).
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 SOP's, specifications, and cGMP regulations.
Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
Decisions have moderate impact on future QC processes and procedures that impact batch disposition. Management System.
Participate in cross-functional teams.
Author new SOP's and initiate changes to existing procedures.
May be required to work overtime or be assigned to a different shift as needed.
Perform equipment maintenance and calibrations as required.
Complete mandatory training within required timeframe.
Perform other duties as assigned.
Education and Experience Requirements
Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework
3 years of relevant experience preferred.
Previous experience in a regulated environment preferred.
Must understand laboratory instrumentation.
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
Knowledge of chemical, biological and/or microbiological safety procedures.
Must display eagerness to learn and continuously improve.
Key Skills, Abilities, and Competencies;
Additional skills include, but are not limited to:
QC Micro Skill Set Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufactuirng Cleanrooms, Aseptic Technique, Critical Utility systems.
Complexity and Problem Solving
Employee at this level is involved in routine tasks of moderate scope and complexity.
Employee receives instructions on new work and refers to policies and procedures for guidance.
Responsible for conducting independent work with minimal guidance from trainers and more senior staff.
Responsible for contributing to moderate scope decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.
Understand the needs of key collaborators (i.e., Manufacturing Operations, Quality Assurance, Validation and Quality Systems) 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, and Business Excellence).
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 QC, 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.
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