- Assist in the equipment and GMP facility set up, operation, and maintenance as required.
- Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of solid, semi-solid, and liquid formulations as needed.
- Document all manufacturing, maintenance and qualification activities and events in logbooks following SOP's and documentation practices.
- Clean GMP and R&D equipment as needed to the standards necessary to meet cleaning validation requirements.
- Maintain, store and monitor inventory of equipment.
- Assist with drafting SOPs, qualification protocols and other GMP documentation.
- Occasionally, perform other related duties and responsibilities as assigned, including raw material and finished product receiving, logging, staging, shipping, etc.
- High School Diploma/GED. Bachelor's Degree in scientific discipline preferred.
- Must be able to read, understand, and follow SOP's.
- Strong oral communication and interpersonal skills
- Ability to perform physical duties including Lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping.
- Potential exposure to particulates, vapors or noisy environment. Must be able to wear Respirator or Dust Mask.
- Experience with cGMP guidelines and regulations is a plus.
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Manufacturing Associate - Exton, United States - Frontage Laboratories
Description
Job Description
Job DescriptionManufacturing Associate
Exton, PA
Full-time
Frontage Laboratories
Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets allowing for the successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.
Position Responsibilities:
Position Requirements:
The ideal candidate will have manufacturing and equipment qualification/cleaning experience in a regulated pharma or biotech environment (GMP, SOPs, etc.).
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
