Catalent Pharma Solutions Hiring for Sr. QC Scientist – Monday – Friday, 8am-5pm at Baltimore, Maryland Full Time

Senior QC Scientist – QC Compliance

Summary:

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.

This is a full-time salaried position. The shift is Monday-Friday, 8:00AM – 5:00 PM.

The Senior QC Scientist -QC Compliance is responsible for supporting compliance in the Quality Control Laboratory, including authoring, management and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action, change control, and other Quality records. This position will facilitate the compiling, trending 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.

Duties and Responsibilities:

• Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.

• Responsible for tracking and trending aspects of Quality Control Systems and provide reports to management identifying risks and trends on a routine basis.

• Works with Quality Systems group to perform QC CAPA effectiveness evaluation based on quantitative and qualitative measurements.

• Maintains tracking mechanisms to support various QC related analytical metrics.

• Continuously monitor and review QC systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QC department.

• Participate in QC compliance remediation plans and implementation.

• Assists with the generation and/or revision of GMP documentation such as standard operating procedures.

• Establish and execute laboratory audit readiness program to ensure a compliance ready state at all times in the laboratory.

• Participates in QC internal audits, as applicable.

• Participate in site quality and process improvement initiatives. Represent QC Analytical on-site project teams.

• Provide protocol generation and execution support for critical facility and utility qualifications and startups.

• Other duties, as assigned.

Skills & Technical Expertise:

• Experience with Good Manufacturing Practices (GMPs)

• Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry, especially within the Analytical / Bioanalytical laboratories

• Experience with ICH Guidelines / USP / EU GMPs

• Ability to quickly learn and navigate electronic systems

• Able to work in a team setting and independently under minimum supervision

• Requires the ability to work and produce results in a fast-paced environment

• Creative individual with excellent trouble shooting skills

Supervision:

• Work independently, under general supervision, to meet department / company goals

MEASUREMENT OF PERFORMANCE

• Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the team

• Timeliness and accuracy in completion of tasks

• Contributions to the team beyond general responsibilities

• Identification of areas for improvement and leads implementation strategies for improvement

• Exercises good judgment

• Demonstrated understanding and adherence to Catalent policies and procedures

• Ability to succeed in a team-oriented environment under dynamic conditions

The Role:

• Has complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines

• Applies technical and functional knowledge to conduct experiments/research in assigned area

• May act as a technical resource within own work group/project team

• Works independently to solve problems of moderate scope

• Actively participates, suggests solutions to problems

• Competent at risk mitigation for function

The Candidate:

• Bachelor’s degree in science field with 5-7+ years of experience, including 2 years GMP experience or other regulated industry required

• Master’s degree in science field with 2-4 years of experience, including 2 years GMP experience or regulated industry or

• PhD in science field with 3-5 years of experience, including 2 years GMP experience or regulated industry preferred

• Must be able to read and understand English-written job instructions and safety requirements

Why Join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Competitive salary with quarterly bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• On-site fitness center and wellness programs

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.