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Senior Scientist QC Compliance - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/20/2024
The Sr. QC Scientist - Compliance role is critical to our patients. This role is responsible for supporting compliance in the Quality Control Laboratory, including authoring, management and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action (CAPA), change control, and other Quality records. This position will facilitate the compiling, trending, completing, and reporting of key quality metrics for management accountability, and other quality control functions, as needed. Continuously monitor systems, logbook management, and testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The role: - Complete Quality Records investigations that meeting both Industry and Catalent expectations
- Initiate and complete the write up and closure of Investigations, Deviations and Change Controls.
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
- Develops, executes, and oversees CAPAs, as appropriate
- Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
- Participate in site quality and process improvement initiatives. Represent QC Department on site project teams.
- Participates in QC internal audits as applicableThe candidate:
- Bachelor's degree in a science or engineering field, preferred
- 4+ years of demonstrated technical competency in a biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory or equivalent experience in a GMP compliance environment (e.g. Quality Assurance, Production, Technical Services, or related field)
- Experience in Quality / Compliance function, in completion of deviation investigations and remediation or significant participation with investigations/deviations/events/etc., within a laboratory setting
- Experience with the analytical and/or bioanalytical testing process and/or EM Microbiology laboratory settings, preferred
- Ability to perform investigation-related interviews and familiarity with root cause analysis
- Previous experience authoring and/or revising technical documentsThe anticipated salary range for this position in Maryland is $93,280-$128,260--plus an annual bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
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