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Scientific Process Operator

Integrated Resources, Inc

Malvern, Pennsylvania

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Biotech and Pharmaceutical, Clinical Research, Concrete, Corporate Compliance, Corporate Policies, Current Good Manufacturing Practice (cGMP), Data Processing, Documentation, Environmental Protection Agency (EPA), FDA (Food and Drug Administration), Federal Laws and Regulations, GMP (Good Manufacturing Practices), Identify Issues, Information Technology & Information Systems, Interpersonal Skills, Manufacturing, Manufacturing Equipment, Manufacturing/Industrial Processes, Microsoft Excel, Microsoft Office, Microsoft Windows Operating System, Microsoft Word, OSHA, Problem Solving Skills, Procedure Development, Production Schedule, Quality Assurance Methodology, Regulations, Regulatory Compliance, Rehabilitation Nursing, SAP, Safety Codes, Standard Operating Procedures (SOP), State Laws and Regulations, Team Player, Technical Operations, Time Management, Trend Analysis
LOCATION
Malvern, Pennsylvania
POSTED
3 days ago
Scientific Process OperatorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionThis position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in Downstream Manufacturing. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.Essential Functions:Executes manufacturing processes according to Technical Operations and Operational Services standard operating proceduresVerifies and enters production parameters per SOP and Batch Record on trained proceduresRetrieves and analyze trend charts and process data on trained proceduresAccurately completes documentation in SOP's, logbooks and other GMP documentsDemonstrates training progression through assigned curriculumAccountable for adherence to compliance policies and regulationsWear the appropriate PPE when working in manufacturing and other hazardous working environmentsTakes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviorsAdditional Responsibilities/Duties:Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.Adheres to the Safety Code of Conduct and attend all required EHS trainingSupport the ongoing production schedule by:Report to work on-time and according to the shift scheduleBe available for other duties as assignedAttend departmental and other scheduled meetingsGood interpersonal and communication skillsDemonstrates positive team-oriented attitude in the daily execution of proceduresPromote and work within a team environmentContinue professional development through learning new skills, procedures, processes and seminarsEssential Functions Per Job Level:Basic Technical Knowledge within functional areaIntroduced to troubleshooting of routine manufacturing processesNeeds direction to perform daily tasksMay offer suggestions for process improvementsBasic GMP understandingAttend PE awareness classes and may participate PE projectsComputer Ability:Computer literateWorking knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is requiredAbility to learn and operate a range of industry systems including SAP Production, Werum MES, Compliance-Kaplan Wire and othersLanguage Skills:Read and interpret documents such as safety rules, operating instructions and logbooksReview and provide feedback for SOP and Batch Record revisions.Reasoning Ability:Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Follows both verbal and written instructions (100% adherence to SOPs)Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization existsWork with high level of concentrationAccept and adapt to procedural changesMathematical Skills:Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.Other Skills, Abilities or Qualifications:Knowledge and ability to operate manufacturing equipment and hand toolsPhysical Demands:While performing the duties of this job, the employee:Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.Is frequently required to talk or hear.While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and armsAbility to lift 20 lbsQualificationsEducation and/or Experience:College degree or HS Diploma with +5 years industrial experienceExperience must be Biotech/Pharmaceutical industry or relevant experience working with Standard Operating Procedures (SOP's) where formal documentation is requiredPrevious experience with MES would be an advantageKnowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage

About the Company

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Integrated Resources, Inc