Planet Pharma
MCS Senior Associate Quality Assurance
Planet Pharma, Thousand Oaks, California, United States, 91362
Overview
Must be flexible as it is possible the worker will start on any shift and rotate every 6 months. Shifts: DAY 6 AM 5 PM; SWING 1 PM 12 AM; NIGHT 7 PM 8 AM. The ideal candidate will have 12+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries. While a bachelors degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, cross-functional environment. This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately. Responsibilities
Support the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Maintain purposeful presence on the floor, perform electronic batch record reviews, revise and approve SOPs, approve work orders, and provide quality approval of minor deviations. Evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. Represent the functional area for the Drug Substance Quality Assurance department in projects necessary to achieve departmental operational goals; work in a team matrix environment. Preferred Qualifications
Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field. Demonstrated ability to perform GMP operations, follow detailed SOPs, maintain training, and uphold good documentation practices. Ability to make quality-based decisions to ensure compliance. Experience managing projects through to completion and meeting timelines. Experience evaluating documentation and operations according to company procedures. Experience working with Quality Systems; strong organizational skills and the ability to manage multiple tasks; effective written and verbal communication. Demonstrated ability to work as both a team player and independently; leadership attributes and drive for improvement initiatives. Job Function
Quality Assurance Industry
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Must be flexible as it is possible the worker will start on any shift and rotate every 6 months. Shifts: DAY 6 AM 5 PM; SWING 1 PM 12 AM; NIGHT 7 PM 8 AM. The ideal candidate will have 12+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries. While a bachelors degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, cross-functional environment. This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately. Responsibilities
Support the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Maintain purposeful presence on the floor, perform electronic batch record reviews, revise and approve SOPs, approve work orders, and provide quality approval of minor deviations. Evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. Represent the functional area for the Drug Substance Quality Assurance department in projects necessary to achieve departmental operational goals; work in a team matrix environment. Preferred Qualifications
Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field. Demonstrated ability to perform GMP operations, follow detailed SOPs, maintain training, and uphold good documentation practices. Ability to make quality-based decisions to ensure compliance. Experience managing projects through to completion and meeting timelines. Experience evaluating documentation and operations according to company procedures. Experience working with Quality Systems; strong organizational skills and the ability to manage multiple tasks; effective written and verbal communication. Demonstrated ability to work as both a team player and independently; leadership attributes and drive for improvement initiatives. Job Function
Quality Assurance Industry
Pharmaceutical Manufacturing
#J-18808-Ljbffr