Specialist, QA OTF

Catalent Pharma Solutions; Harmans (MD); On-site; USD 74,000 - 102,000; Full time

Job summary

Join an innovative organization dedicated to improving lives through advanced therapeutic products. As a QA Specialist, you will play a crucial role in ensuring the quality and compliance of manufacturing processes for life-saving therapies. Your expertise will guide the production of master cell banks and drug products, making a significant impact on patient health. This full-time position offers a dynamic work environment where your contributions will directly enhance the quality of healthcare. With competitive benefits and a commitment to excellence, this is an exciting opportunity for those passionate about making a difference in the pharmaceutical industry.

Benefits

152 hours of paid time off annually

8 paid holidays

Competitive salary with yearly bonus potential

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

Community engagement initiatives

Career growth opportunities

Qualifications

• 0-4 years experience in Quality Assurance/Quality Control/Manufacturing.
• Strong understanding of GMPs and biological manufacturing processes.

Responsibilities

• Provide QA oversight of GMP operations for drug manufacturing.
• Review batch documentation and ensure compliance with standards.
• Participate in quality and process improvement initiatives.

Skills

GMP Compliance

Quality Assurance

Analytical Skills

Troubleshooting

Decision Making

Collaboration

Education

Master's in Scientific, Engineering or Biotech field

Bachelor's in Scientific, Engineering or Biotech field

Tools

LIMS

Master Control

Trackwise

Microsoft Office

Job description

Specialist, QA OTF

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.

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from ourBaltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

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.

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Specialist, QA 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 is a full-time on-site position, 7am-7pm 2-2-3 rotation

Catalent is committed to a Patient First culture through excellence in quality andcompliance, 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 – 75% 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.
• Partner with Manufacturing and other support teams
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Review and approve batch documents for media and buffer prep solutions
• Generate or revise 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
• 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 – 75% of day is spent on the floor.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
• Make solid quality decisions with limited oversight
• Identify and implement and continuous improvement initiatives
• Participate in site and corporate quality and process improvement initiatives.
• 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 0 - 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 2 - 4 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
• Strong understanding of GMPs (21 CFR Parts 210, 211, 600s), ICH, and EU GMPs. Familiarity with biological manufacturing processes (microbial/cell culture, fermentation, purification, fill/finish).
• Knowledgeable in applying scientific and regulatory principles to solve operational and quality tasks.
• Familiar with electronic systems (Microsoft products; LIMS, Master Control, Trackwise preferred) and possesses strong analytical, troubleshooting, and decision-making skills.
• Adaptable and proactive, capable of learning new processes quickly, working independently and collaboratively to meet deadlines in a fast-paced environment.

The anticipated salary range for this position in Maryland is $74,080 -$101,860 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.

Position Benefits:

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually +8paid holidays
• Competitive salary with yearly 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

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 [e-mail]. 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 [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.