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OVERALL RESPONSIBILITIES: Maintains an effective organization through the selection, training, development and engagement of all direct reports. Promotes open door policy, diversity, continuous improvement and a safe environment. Enforces adherence to all company policies, procedures and regulations. Ensures compliance with guidelines from the domestic and international regulatory agencies (FDA, OSHA, EPA, Police Department, DEA, ICH, etc.), Neolpharma policies and procedures related to cGMP’s, safety and environmental control. Supports Cediprof and CMO business for all requested testing activities. Primary functions: 1.Maintain the laboratories in full compliance with cGMP’s and Company procedures.2.Provides leadership to laboratory areas including Laboratory Analysts.3.Monitors and manages the efforts of subordinate colleagues to achieve short term goals.4.Responsible for managingIoverseeing laboratory resources such as headcount, supplies, budget to ensure compliance with product demands.5.Performs capacity analysis based on production forecast effectively identifies and implement laboratory efficiency improvements.6.Prepare Laboratory schedule for testing and data verification to assure lots are released within cycle time to support plant requirements.7.Prepares Laboratory weekly to assure materials are released within cycle time established.8.Prepare Monthly report to highlight all laboratory accomplishments performed during the month.9.Follow-up on Purchase requisitions to assure availability of all necessary materials.10.Assures that materials are released in compliance with the current pharmacopeia monographs if applicable.11.Revises procedures, test methods and specifications following current procedures.12.Generates, reviews or approves Laboratory Investigations following current procedures and ensure CAPAs are taken to avoid reoccurrence.13. Generates, reviews or approves any protocol as required for method verification /validations following current procedures. 14.Tracks Laboratory Investigations to assure completion within the timeframe established. Identify any laboratory error trend and prepare plan to avoid recurrence.15.Generates and routes for approval Change Control and CAPAs as required to support laboratory activities. Coordinate all required activities to complete project within established timeframe.16.Assures laboratory compliance with Stability Program, Instrumentation and Test Method Verification/Validation guidelines and procedures.17.Assures that all laboratory personnel have the necessary training and qualifications required to perform the assigned tasks. 18.Performs other duties as assigned.Secondary functions: N/ASupervisory Responsibilities: The incumbent will supervise Laboratory Technicians, Laboratory Analysts and QO Clerk.Minimum Requirements: 1.Bachelor’s or master’s degree in science (Chemistry, Biology, Microbiology or Biotechnology) is required.2.Three to five years of experience in quality control field, analytical development or analytical technical support area. With at least two (3) years of supervisory experience.3.Leadership, self-motivation, integrity, adaptability, self-development and teamwork oriented is a must for this position.4.Bilingual (Spanish/English) communication skills, both written and verbal are required.5.Knowledge of the cGMP’s and other regulatory guidelines.In depth understanding/knowledge of:•cGMP, EHS, other related regulatory requirements and Controlled Substance•Computer Literacy (Microsoft Office, Business Application)•Excellent communication skills in English and Spanish•Strong communication skills (written and verbal)•Must possess flexibility to respond to constantly changing conditions and prioritiesOther Requirements: •Willing to work other shifts as per company needs.Neolpharma Inc. is an Equal Employment Opportunity /Affirmative Action Employer committed to hiring a diverse and inclusive workforce. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. Neolpharma provides equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.Neolpharma provides information to employees on the Federal laws prohibiting job discrimination based on race, color, sex, national origin, religion, age, equal pay, disability and genetic information. The EEO is the Law poster provides this information and may be accessed https://www.eeoc.gov/employers/eeo-law-poster. If you need an alternative format of the poster, you may request one by email at talentacquisition@neolpharma.com or phone: (787) 286-4000. Accessibility AccommodationIf you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access www.neolpharmapr.com/Careers site as a result of your disability. You can request reasonable accommodation by sending an e-mail to talentacquisition@neolpharma.com or by calling (787) 286-4000 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.EEO Employer/Affirmative Action for Females/Disabled/VeteransApply: http://www.neolpharmapr.com