Senior Specialist QA OTF

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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

Catalents Harmans/BWI MD facility is a FDAlicensed stateoftheart CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI1 EMA and FDA approved facility at approximately 200000 sq. ft. houses 10 CGMP manufacturing suites fill/finish central services testing labs and a warehouse. The Harmans/BWI2 facility at approximately 145000 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 vectorbased therapies and vaccines.

The Sr. Specialist QAOTF 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 OnTheFloor (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 7PM7AM 223 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 SMPs; 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 inprocess 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 Bachelors 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 decisionmaking 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 fastpaced environment to meet client deadlines

The anticipated salary range for this position in Maryland is $93280$128260 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 multistate 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 fastpaced 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 7000 lifesaving and lifeenhancing 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 . 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 for us to investigate with local authorities.

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