Position: Manufacturing Associate I

　　Location: Harmans, MD

　　Duration: 6 + months

　　DURATION - 6 MONTHS

　　SHIFT - 7AM - 7PM ROTATE SCHEDULE EVERY 2 WEEKS 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.

　　POSITION SUMMARY

　　The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.

　　Shift work and/or weekend work may be required at times.

　　KEY RESPONSIBILITIES

　　Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.

　　Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.

　　Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.

　　Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s

　　Performs the weighing, dispensing of raw materials for media and buffers

　　Performs the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.

　　Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.

　　Dispensing, labeling, transfer/staging of raw materials and parts

　　Assembly/disassembly, cleaning and sterilization of components, parts, and equipment

　　Maintaining equipment, area, and cleaning logbooks

　　Cleaning sanitizing production rooms and equipment

　　Stocking production and cleaning supplies

　　May author/ review/improve SOP’s, batch records, protocols, and technical reports

　　Actively participates in training activities, managing their individual training plan.

　　Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.

　　Other duties as assigned

　　POSITION REQUIREMENTS:

　　High School Diploma with a minimum of 2-4 years GMP Manufacturing experience

　　OR

　　Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience ; coursework with biotechnology focus highly desirable,

　　OR

　　Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience

　　Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company.

　　General understanding of most areas in Manufacturing and supporting functional groups.

　　Familiar with or experience with cGMP Biotech or Pharmaceutical operations:

　　Must be team-oriented (proactively builds healthy working relationships between peers, their department, and other groups).

　　Able to fluently communicate in English.

　　Exhibits excellent written and oral communication skills.

　　Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.

　　ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.