Share Email Opening Title Metrologist I or II  Category Facilities   Description Metrologist I - Assist in the calibration and maintenance activities at the Gainesville Site, operating within guidance provided by the Site Calibration Program. Coordination with external calibration resources to support the Gainesville Site as needed. Develop technical calibration expertise in all areas with a focus on assigned area. Metrologist II -Performance of calibration and maintenance activities at the Gainesville Site, operating within guidance provided by the Site Calibration Program. Supervision of outside contractors supporting the Gainesville Site. Provision of technical guidance in area of expertise as well as drafting and review of technical GMP documentation such as investigations and standard operating procedures. Metrologist I Calibration and Maintenance Responsibilities (85%) Develop calibration work schedules for equipment and schedule such activities with supervision to ensure maximum uptime of related equipment. Perform calibration, maintenance, and repair of instrumentation. Schedule and coordinate outside contractors as needed and track instrumentation sent offsite for service and calibration. Review and approve calibrations performed on equipment by external calibrators. Technical Expertise and Documentation Responsibilities (10%) Develop calibration expertise to be able to provide technical input and evaluations for calibrations of instrumentation. Assist in researching the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria. Develop the ability to initiate, review and edit required standard operating procedures, standard certification methods, and other instructions in compliance with FDA, USP, NIST or other applicable guidelines for equipment. Assist in verifying that specific procedures for periodic verification of instruments are technically accurate and consistent with the calibration procedure for the instrument and any applicable calibration department guidelines. Learn to perform appropriate investigations and write related instrumentation deviations when equipment is found out of calibration and maintenance acceptance criteria. Other Responsibilities (5%) Assist in execution of corrective actions and change control requests for changes affecting calibration of laboratory equipment. Learn to initiate and close out deviations, CAPA's, and change controls focused on calibration activities. Identify possible continuous improvement initiatives within area of responsibility. May be assigned to plan, organize and lead initiatives within scope and technical expertise developed. Metrologist II Calibration and Maintenance Responsibilities (75%) Provide first line oversight responsibility for the site calibration program. Develop calibration work schedules for equipment and schedule such activities with supervision to ensure maximum uptime of related equipment. Perform calibration, maintenance, and repair of instrumentation. Supervise outside contractors and supervise instrumentation sent offsite for service and calibration. Review and approve calibrations performed on equipment by both internal and external calibrators. Technical Expertise and Documentation Responsibilities (15%) Provide technical input and evaluations for calibrations of instrumentation. Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria. Write required standard operating procedures, standard certification methods, and other instructions in compliance with FDA, USP, NIST or other applicable guidelines for equipment. Assure that the specific procedures for periodic verification of instruments are technically accurate and consistent with the calibration procedure for the instrument and any applicable calibration department guidelines. Perform appropriate investigations and write related instrumentation deviations when equipment is found out of calibration and maintenance acceptance criteria. Other Responsibilities (10%) Initiate, execute, and close out corrective actions and change control requests for changes affecting calibration of laboratory equipment. Assist validation personnel with execution of validation of instrumentation. Plan, organize, lead, and control continuous improvement initiatives within area of responsibility.   Position Requirements Metrologist I: Education Minimum of an Associate’s degree in a related science or engineering discipline is required. Equivalent trade, military or relevant technical training may be considered in lieu of formal degree. Experience Minimum of 1 year of experience in a calibration related role is highly preferred. Will consider related technical work experience with equipment that is routinely calibrated and within a highly regulated industry. Metrologist II: Education Associate’s degree in science discipline. Experience Five (5) years of experience. Must have direct experience with a comprehensive metrology program capable of meeting appropriate regulatory requirements. Knowledge/Skills/Abilities Excellent written, verbal, and interpersonal skills. Ability to adapt to changes in work environment, work assignments, and/or changes in priorities. Excellent organization, time management, customer service, and problem-solving skills. Ability to complete work accurately and meet internal/external deadlines. Ability to use analytical and decision-making skills to offer options and resolve problems. Ability to work independently as well as part of a team. Ability to arrive at technically sound solutions which conform to GMP principles and site objectives. Proven intermediate skills with Microsoft Office (Word and Excel). Working knowledge of a computerized equipment management system such as Maximo or similar. General knowledge of how to calibrate instruments typically found in a GMP solid oral dosage facility. General knowledge of pharmaceutical water systems. Ability to perform basic repair on general instrumentation. Ability to work in a GMP environment and apply GMP documentation and work practices. Ability to draft technically sound GMP documentation such as investigations, technical justifications, standard operating procedures, work orders, change controls, and corrective actions. Physical and Mental Demands and Work Environment The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical Demands While performing the duties of this job, the employee is regularly required to use hands to finger handle or feel. The employee frequently is required to stand. The employee is occasionally required to walk; sit; reach with hands and arms; stop, kneel, crouch, or crawl; and talk or hear. The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements. Mental Demands While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, manage contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, spreadsheet and is occasionally required to apply computer skills using presentation software. The employee is regularly required to apply mathematical formulae to tasks such as basic statistical methods for analyzing raw data and execute technical calculations. Work Environment In certain assignments, the employee will occasionally work around fumes, airborne particles and chemicals, which may require the employee to wear specified Personal Protective Equipment The noise level in the work environment is usually moderate.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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