Penn Foster
Senior Associate Scientist, EM Data Analyst
Penn Foster, Sanford, North Carolina, United States, 27330
Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Senior Associate Scientist, EM Data Analyst.ABOUT INCLUSIVELY:Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD).
Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.How You Will Achieve ItThe successful candidate will become a subject matter expert on the laboratory operations needed to support viable and non-viable environmental monitoring and qualified utilities testing in a highly regulated and controlled GMP manufacturing environment.The successful candidate will assist in the overall operation of the laboratory including: review and approval of environmental monitoring results, continuous improvement of current processes, ensure ordering lab supplies/quantities do not get below inventory level, evaluation of sampling practices against regulatory standards to ensure continued compliance, assisting with deviation investigations and corrective action/preventative action creation and execution, creation/revision of EM risk assessments, and creation and revision of standard operating procedures.The candidate will be responsible for individual contributions to achieve team deliverables. May perform work independently, or as an integral member of a team.Interacts with other team members in the laboratory, within the Microbiology department, and with colleagues from other departments (Operations, Quality, Maintenance/Engineering, and Regulatory). Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Microbiology laboratories.Write PQ validation protocol and reports and perform associated data analysis.Operate within established HR policies and basic colleague relations guidelines.Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.Contribute to the completion of team objectives and assigned project milestones.Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.QualificationsMust-HaveApplicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+ years of experienceExperience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.Understanding of aseptic laboratory techniques and quality systems.Ability to establish relationships within business lines.Excellent effective written and verbal communication and interpersonal skills.Nice-to-HaveExperience in Quality Operations.Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA.Experience leading continuous improvement projects is a plus.Physical/Mental RequirementsAbility to analyze complex data and evaluate microbiological results is required.Ability to complete aseptic gowning qualification.Long periods of standing, walking, and/or sitting may be needed.Occasional lifting (less than 35 lbs), and reaching may be required.Extended time working at a computer terminal is also required.Non-Standard Work Schedule, Travel, or Environment RequirementsThis role is standard day Monday through Friday work shift: 7:30 AM – 4:00 PM, 5 days/week.On-Call, Weekend, and/or Holiday hours may be required in order to meet business and/or customer needs.No Travel.Other Job Details:Last day to Apply: August 23rd, 2023.Eligible for Relocation Assistance: NO.Work Location Assignment: On Premise.Job Type: Full-timeSchedule:Holidays.Monday to Friday.On call.Weekends as needed.Work Location: In person.
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Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.How You Will Achieve ItThe successful candidate will become a subject matter expert on the laboratory operations needed to support viable and non-viable environmental monitoring and qualified utilities testing in a highly regulated and controlled GMP manufacturing environment.The successful candidate will assist in the overall operation of the laboratory including: review and approval of environmental monitoring results, continuous improvement of current processes, ensure ordering lab supplies/quantities do not get below inventory level, evaluation of sampling practices against regulatory standards to ensure continued compliance, assisting with deviation investigations and corrective action/preventative action creation and execution, creation/revision of EM risk assessments, and creation and revision of standard operating procedures.The candidate will be responsible for individual contributions to achieve team deliverables. May perform work independently, or as an integral member of a team.Interacts with other team members in the laboratory, within the Microbiology department, and with colleagues from other departments (Operations, Quality, Maintenance/Engineering, and Regulatory). Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Microbiology laboratories.Write PQ validation protocol and reports and perform associated data analysis.Operate within established HR policies and basic colleague relations guidelines.Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.Contribute to the completion of team objectives and assigned project milestones.Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.QualificationsMust-HaveApplicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+ years of experienceExperience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.Understanding of aseptic laboratory techniques and quality systems.Ability to establish relationships within business lines.Excellent effective written and verbal communication and interpersonal skills.Nice-to-HaveExperience in Quality Operations.Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA.Experience leading continuous improvement projects is a plus.Physical/Mental RequirementsAbility to analyze complex data and evaluate microbiological results is required.Ability to complete aseptic gowning qualification.Long periods of standing, walking, and/or sitting may be needed.Occasional lifting (less than 35 lbs), and reaching may be required.Extended time working at a computer terminal is also required.Non-Standard Work Schedule, Travel, or Environment RequirementsThis role is standard day Monday through Friday work shift: 7:30 AM – 4:00 PM, 5 days/week.On-Call, Weekend, and/or Holiday hours may be required in order to meet business and/or customer needs.No Travel.Other Job Details:Last day to Apply: August 23rd, 2023.Eligible for Relocation Assistance: NO.Work Location Assignment: On Premise.Job Type: Full-timeSchedule:Holidays.Monday to Friday.On call.Weekends as needed.Work Location: In person.
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