Lead Technician, Batch Disposition (2nd Shift)
Company: Disability Solutions
Location: Hanover
Posted on: October 25, 2024
Job Description:
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--. 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, M-F 1pm-9:30pmCatalent
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 ReimbursementCatalent 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 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
spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Burke , Lead Technician, Batch Disposition (2nd Shift), Professions , Hanover, Virginia
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