Senior Specialist, QA OTF

Catalent Pharma Solutions; Harmans (MD); On-site; USD 93,000 - 129,000; Full time

Job summary

An established industry player is seeking a Senior Specialist for Quality Assurance in a cutting-edge facility. This role focuses on overseeing GMP manufacturing processes for life-saving therapies, ensuring compliance with regulatory standards. The ideal candidate will possess a strong background in quality assurance within biologics, with a commitment to excellence and patient safety. Join a dynamic team dedicated to innovation and quality in a fast-paced environment, where your contributions will directly impact the health and well-being of patients. This is a fantastic opportunity to grow your career in a supportive and rewarding workplace.

Benefits

Defined career path

401K match

Paid Time Off

Medical, dental and vision benefits

Tuition Reimbursement

Wellhub program

Exclusive discounts through Perkspot

Qualifications

• 2+ years in QA/QC/Manufacturing within biologics or regulated industry.
• Familiarity with GMPs and biological manufacturing processes.

Responsibilities

• Provide QA oversight for GMP operations and documentation.
• Perform audits and identify continuous improvement initiatives.

Skills

Quality Assurance

Good Manufacturing Practices (GMP)

Analytical Skills

Troubleshooting

Decision-Making

Teamwork

Education

Master's degree in Scientific, Engineering or Biotech field

Bachelor's degree in Scientific, Engineering or Biotech field

Tools

Microsoft Office

LIMS

EDMS

Trackwise

Job description

Senior Specialist, QA OTF - Night Shift

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Sr. Specialist, QA-OTF is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. This position is Night Shift 7PM-7AM 2-2-3 schedule and is 100% on site at BWI/Harmans, MD facility.

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:

• Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 80% of day is spent on the floor.

• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing; partners with Manufacturing and other support teams.

• Performs Acceptable Quality Limit (AQL) visual inspection of drug product; reviews and approves batch documents for media and buffer prep solutions; generates or revises GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP’s; compile deviations as required when observed on the floor, and move to completion within the required time frame.

• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.

• Identifies and implements continuous improvement initiatives; participate in site and corporate quality and process improvement initiatives; makes solid quality decisions with limited oversight.

• Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

• Actively participates in training activities, managing their individual training plan.

• Other duties as assigned.

The Candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 2+ years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 4+ years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish; have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.

• Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, EDMS and Trackwise knowledge preferred.

• Creative individual with excellent analytical, trouble shooting, and decision-making skills; ability to quickly learn new and novel manufacturing processes supporting new clients.

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

• Requires the ability to produce results in a fast-paced environment to meet client deadlines.

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus shift differential and annual bonus, when eligible. 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:

• Defined career path and annual performance review and feedback process
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• Wellhub program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.