Posting ID: JP-002659875
Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Operates general manufacturing equipment, such as autoclaves, and automated aseptic filling lines. Handles raw materials and intermediate or finished products.
• Assists in all direct manufacturing support functions such as Thaw, Blend, Fill, Stage, Prep, Environmental and Monitoring (EM) and equipment preparation.
• Assists in indirect manufacturing support functions, such as cleaning and sanitization of the facility.
• Performs standard operating procedures to meet current good manufacturing practices (GMP).
• Accurately completes required documentation to comply with Federal regulations and assists with batch-record close-out.
• Maintains product related records as required.
• Author and revisor of SOPs and Batch records as needed.
• Responsible for all aspects in the aseptic manufacturing of product to ensure product quality and patient safety.
• Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
• Operates basic equipment (i.e. scale and/or balance, autoclave, pH meter, environmental monitoring equipment) as delineated in standard operating procedures.
• Prepares and formulates specially cleaners and/or solutions, etc. needed for cleaning and/or to be used in the manufacturing processes and/or support areas were specified by standard operating procedures.
• Carry out assignments in a timely, diligent and safe manner to comply with Regulatory agencies both domestic and international (i.e. CFR, EMEA).
• Accurately complete documentation to comply with FDA and GCP/GLP/GMP regulations.
Additional Skills & Qualifications:
* 0-4 years related experience or training in a pharmaceutical manufacturing environment. 0-2 years related experience or training with an Associates degree and/or 4-year degree in Science or Life Sciences field. Academic coursework in a related science field, and/or applicable certifications, and/or practical relevant work experience may be used in substitution and/or in conjunction with no college degree.
* Clean room work experience, food, medical device and/or pharmaceutical manufacturing or aseptic processing and/or assembly experience, which may include environmental monitoring, pharmaceutical warehousing, pharmaceutical packaging experience is acceptable. Certifications and licenses that are relevant are acceptable.
* Pharmaceutical experience is preferred, but not required. Training will be provided.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072