Vacancy caducado!
Position Summary: Location: Duarte, CA Responsible for assisting the QA Manager and Senior QA Associate in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the GMP facilities. Assists with distribution, tracking and archiving of clinical materials. Assists with audits, inspections, and staff in-service training as necessary. Essential Functions: 20% Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP). 20% Reviews production output batch records and assures that the proper procedures and processes have been used in the production of the products prior to approval by QA Manager. Compile master production and control batch records and archive documents. 15% Assists QA Facilities manager for the continuous operation of the facility's mechanical systems, monitoring systems and equipment. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Facilities Manager. 10% Conduct internal cGMP and safety training to manufacturing staff, may provide training to new staff and will be OQS lead on manufacturing projects. 10%
Initiate OOS/CAPA investigations, propose resolutions and process related forms. Writes reviews and processes the approval of Standard Operating Procedures and quality policies. 10% Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash. 5% Present project updates at project meetings and to management as requested. Participate in audits and interact with collaborators. May be required to attend off-campus training or training seminars. 5% May be required to conduct external vendor audits. Interact with internal departments (purchasing, safety etc) as directed. Communicate with external vendors as directed, to co-ordinate release test activities, and materials processing. 5% Wear pager, or other communication devices, and respond to emergency calls as needed. Follows established department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. Performs other related duties as assigned or requested. Position Qualifications: Minimum Education: BS or BA Minimum Experience: 5+ years of experienceRequired Courses/Training: Basic biology, chemistry, virology or engineeringReq. Certification/Licensure:Preferred Education: MS degree preferred with 3+ years of experience.Preferred Courses/Training: Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry) GMP facility operations Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.Pref. Certification/Licensure: Certification from ASQ or other professional organization /recognized institutions related to quality (i.e. quality auditor, quality manager, facility operations). Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing.Experience: Preferred experience may vary according to QA team focus (i.e. supporting biologics manufacturing, small molecule synthesis, GMP facility operations)Skills/Abilities: Required: Excellent written and oral communication skills, team player, self-motivated, excellent personal hygiene, practice good judgment in all professional activities. Ability to analyze data and compose reports. Ability to set and model professional work standards. Foster and promote a positive image and professional appearance Autonomous and self-directed Demonstrated laboratory skills Knowledgeable about State and Federal regulatory requirements Able to correctly use technical terms and abbreviations Excellent organizational skillsSoftware: Microsoft Access Database: Required Microsoft Excel: Required Microsoft Windows NT: Required Microsoft Word: Required Microsoft Project / PowerPoint: Preferred Labware / LIMS: PreferredMachines/Equipment: Personal computer: Required Photocopier: Required Audiovisual equipment: Required Environmental monitoring equipment: Preferred Autoclave, Glassware washer, Depyrogenation oven, RODI system, and Pure Steam Generator: PreferredWorking / Environmental Conditions: State of the art GMP drug manufacturing facility. Exposed to materials of confidential nature on a regular basis. Atmosphere and environment associated with an office setting Atmosphere and environment associated with a laboratory Tobacco-free campus Subject to many interruptions Subject to long irregular hours Occasional pressure related to timeframes May require a flexible work schedule Subject to regularly changing priorities and work assignments Gowning according to facility requirements. This includes hair covers, shoe covers, gloves, facemasks, eye protection; occasionally full one piece suits with hoods. Other safety precautions and practices as specified by the safety regulationsPhysical Demands: Light physical effort (lift/carry up to 20 lbs.) Frequent walking Some reaching, stooping, bending, kneeling, crouching Tasks require focused concentration Comfortable on high exposed work places (roof).If interested, please send your resume to Schuyler Harris EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at orVacancy caducado!