Manufacturing Associate Exton, PA Full-timeFrontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.Position Responsibilities:
- 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.
Position Requirements:
- 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.
The ideal candidate will have manufacturing and equipment qualification/cleaning experience in a regulated pharma or biotech environment (GMP, SOPs, etc.).Salary and Benefits:Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.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.