POSITION SUMMARY:
Under general direction of the Analytical Development and Projects Supervisor, you will be primarily responsible for Method Verification in launching finished product and project-based activity including equipment management QC routine testing of finished product and compliance with cGMP’s. In addition, you will support the regulatory requirements of finished product, and investigation of product issues.
This job position is compliance critical, and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Ensures compliance with cGMP’s, Environmental, Health and Safety regulations.
- Prepares and executes method verification of test methods and protocols for the laboratory.
- Supports the introduction of new laboratory equipment and materials.
- Ensures laboratory equipment is calibrated and properly maintained at all times.
- Develops and implements Standard Operating Procedures.
- Executes all analytical verification activities to ensure timely and compliant launch of finished products.
- Executes routine Quality Control testing as required to ensure timely and compliant release of finished products.
- Supports the document control system and record retention.
- Promotes the maintenance of a safe, accident free and healthy work environment.
- Performs related duties as assigned.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
- BSc in a scientific discipline
- Minimum of two (2) years in a cGMP facility in a Quality Control role
- Experience in HPLC (High Performance Liquid Chromatography) is required.
MINIMUM SKILLS, KNOWLEDGE, AND ABILITY REQUIREMENTS:
- Excellent oral and written communication skills
- Ability to effectively participate in cross-functional problem-solving teams.
- Ability to read and understand the English language for the purpose of following instructions.
- Ability to develop and maintain cooperative working relationships with others.
- Ability to use good judgment in order to carry out detailed instructions.
- Ability to work independently.
- Excellent teamwork and interpersonal skills.
- Ability to handle a variety of tasks simultaneously.
- Good problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
- Attention to detail.
- Computer literate.
- Good knowledge of Quality Assurance, cGMP and GLP.
- Experience in using HPLC in a GMP environment.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is generally quiet to moderate.
PHYSICAL AND MENTAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
- Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
- Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
- 10% or more time is spent looking directly at a computer.
- Associate is frequently required to stand, walk (or otherwise be mobile).
- Ability to deal with stressful situations as they arise.
- Working in a laboratory environment.
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