Lead Technician, QA - Batch DispositionSummary: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 our Baltimore 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.
The Lead Technician, QA - Batch Disposition is responsible for providing QA Operations support on maintaining, filing and scanning of batch records and supporting documentation. This role is also responsible for the timely data entry and maintenance of batch review life cycle tracker and visual boards.
This is a full-time on-site position, Fri-Sun 8:30am-9pm 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:- Responsible for the organization and maintenance of executed manufacturing batch records and supporting GMP documentation to support batch disposition
- Review of terminated, discontinued and rejected batch records and other GMP documents as applicable.
- Responsible for the accurate and efficient systems to storage, cataloging and retrieval of in-process GMP documents directly supporting batch disposition.
- Conduct training for QA employees on efficient system usage.
- Uploads GMP documents into designated network locations for review and retrieval
- Responsible for in-process GMP document security and tracking
- Responsible for accurately maintaining batch record status database and visual board.
- Communicate effectively and frequently with personnel to obtain information necessary to maintain tracking tools up to date.
- Actively participates in training activities, managing their individual training plan.
- Other duties as assigned.
The Candidate:- High school diploma and 3 - 5 years' experience within biologics, biopharmaceuticals, or a regulated industry.
- Knowledge of using an EDMS and ability to create workflows and reports from these systems
- Knowledge of Good Manufacturing Practices (GMPs) and 21 CFR part 11
- Hands on experience with an EDMS creating documents for a GMP environment.
- Expert in formatting in Microsoft Word and use of edit tools.
- Good communication skills and ability to work in a group setting where priorities may be shifted weekly
- Ability to work in a cross functional team and escalate concerns related to priorities and patient first concepts
- Requires the ability to produce results in a fast-paced environment to meet client deadlines
- 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 projects and paperwork (quantity and quality of work)
- Identification of problem areas affecting workload expectations (knowledge/problem solving)
- Offers suggestions for correcting problems and creating more lean processes
- Demonstrated understanding and adherence to Catalent policies, safety procedures and the cGMPs
- Ability to succeed in a team-oriented environment under very dynamic conditions
The anticipated salary range for this position in Maryland is $47,600- $65,450 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 + 8 paid 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 ...@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.