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    Analytical Research and Development Analyst - Morrisville, United States - The Staffing Resource Group Inc

    The Staffing Resource Group Inc
    The Staffing Resource Group Inc Morrisville, United States

    3 weeks ago

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    Description
    Job Description

    Analytical Research & Development Analyst II

    SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
    • Location: Morrisville, North Carolina
    • Industry: Pharmaceutical
    • Salary: Up to $35/hr. depending on experience
    • Schedule: Monday-Friday, 8am-5pm
    • Employment Type: Contract (potential to go permanent)
    Client Overview: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.
    Department Overview: The Analytical Research and Development (ARD) departments the Analytical Sciences organization are responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other facilities.
    Job Summary:
    The AR&D Analyst II works under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. Comply with divisional and site Environmental Health and Safety requirements.
    Responsibilities:
    • Execute laboratory work plan/schedule with input from supervisor or senior team member.
    • May draft technical documents such as methods or certificates of analysis.
    • Performs real-time review of laboratory documentation and may become qualified to perform technical review of documents for accuracy, thoroughness, and regulatory compliance.
    • Trains others on procedures and laboratory techniques.
    • Participate in efficiency improvement project with guidance.
    • All other duties as assigned.
    Education Requirements:
    • Master s degree and 0-2 years related experience; Bachelor's degree and 3-5 years related experience; or Associate s degree and >6 years related experience or equivalent education, experience, and training.
    Knowledge, Skills and Abilities:
    • All employees must receive training on the fundamental principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity, and employee conduct as a condition for performing GxP activities.
    • All employees performing GxP activites must be trained, at least annually, on the requirements established for GxP Documentation and Data Integrity.
    • Pharmaceutical or related GMP/GLP experience needed.
    • Perform method validation independently and nice to have method development.
    • Experience with HPLC, GC, and Empower.
    • Execute procedures or methods with high quality.
    • Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
    • Propose improvements to established procedures and methods based upon sound judgment.
    • May contribute material to publications and/or external presentations.
    • Authors test methods and text reports.
    • Conducts Trackwise investigations.
    • Ability to learn and retain technical information.
    • Proactively address work issues at both an individual level and a team level.
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
    • Mathematical and scientific reasoning ability.
    • Basic understanding of instrument operations and troubleshooting skills in multiple techniques.
    • Ability to identify aberrant/out of spec data and limited interpretation of data expected.
    • Excellent written and verbal communications skills.
    • Lead by example according to our values and culture.
    • Recognizes unmet needs within department.
    • Strategy is focused on personal time management and efficiency.
    • Well organized with ability to multitask.
    • Ability to work effectively under pressure to meet deadlines.
    • Has applied knowledge of the principles and concepts of a technical discipline.
    • Applies technical and functional knowledge to job related duties on projects/assignments.
    Physical Requirements:
    • On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.
    • Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.
    • May require the use of a respirator.
    EOE/ADA

    #LI-SRG1

    IND123


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