Administrative / Office Assistant

Krystal Biotech•Moon Township, PA

1d•Onsite

About The Position

Krystal Biotech, Inc is seeking a highly motivated Administrative Assistant to support multiple departments at our Astra facility in Moon Township. The primary focus will be two-fold; in performing general administrative and front-desk duties, while also supporting Quality document control, in ensuring facility compliance with all internal procedures, cGMP’s, and regulatory guidelines.

Requirements

Bachelor’s degree preferred, or equivalent combination of education and professional experience.
Ability to maintain confidentiality and work with sensitive documents.
Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking.
Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure.
Demonstrated ability to prioritize and manage multiple projects simultaneously.
Excellent interpersonal, collaboration and stakeholder management skills.
Excellent communication skills (written/verbal).

Nice To Haves

Knowledge of FDA regulations and industry standard guidelines for electronic records, a plus.

Responsibilities

General office organization and maintenance.
Keeping the conference rooms, office and kitchen areas cleaned and stocked.
Office supply ordering and tracking.
Coordination of conference room bookings.
Greet all visitors and ensure company sign-in policy is followed and/or answer the visitor arrival phone when applicable.
Ensure coverage is available for the front desk during all breaks.
Assist with shipping and receiving as required.
Issue controlled documents, such as batch records, labels and sampling plans, while adhering to specific format standards and guidelines
Assist with data entry and administrative tasks to support access control for the Astra location as well as maintain the log for access logins.
Support controlled document life cycle/retention procedures.
Supports with internal and external audits and regulatory inspections, to include retrieval of GMP documentation.
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Maintains an awareness of evolving industry standards for document generation and electronic document management.
Maintains Document Control Room(s) in an inspection ready state. Ensures all paperwork is distributed, reconciled, archived, and filed in a timely manner.
Other duties as assigned.