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 ensurecompliance 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 applicable
The 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 documents
The 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:- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to ...@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ...@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.