QA Sterility Assurance - Sterility Assurance Specialist I

Minaris•Philadelphia, PA

1d•Onsite

About The Position

Responsible for producing documents for sterility assurance related programs, providing aseptic processing oversight, and technical support to manufacturing operations to ensure contamination control. Acts as the Primary Sterility Assurance Representative and effectively collaborates with multi-disciplinary teams for designated projects.

Requirements

Knowledge of GLP and cGMP guidelines is required.
Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
Ability to evaluate technical data and write technical documents.
Ability to use judgment as dictated by complexity of situation.
Ability to work under limited supervision and to handle problems of a difficult nature.
Ability to accomplish the duties described through the use of appropriate equipment and software.
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
Ability to record data accurately and legibly.
Ability to understand and follow verbal or demonstrated instructions.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)

Responsibilities

Authors and reviews qualifications such as environmental monitoring performance qualification (EMPQs), aseptic process validations (APVs), and airflow visualization (smoke studies).
Owns change control tasks associated with qualification or program revisions
Authors risk assessments in support of microbial control strategy and sterility assurance programs
Performs aseptic processing training for manufacturing and support personnel
Participates in continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance
Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff
Authors new and revised procedures for Sterility Assurance department.
Data approval in EMDS system
Coordinates with Project teams in design, set up and execution of projects
Maintains current regulatory knowledge, staying up to date with best practices and sharing knowledge
Participates in business excellence projects within SA and across site
Ability to work in a team environment and independently as required
May be required to work Holidays and weekends
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
May be required to assist in other departments