- Operate processing equipment in accordance with SOPs, in all classified areas (ISO 7, ISO 8, ISO 5)
- Complete all necessary paperwork associated with investigations, deviations and remarks.
- Use proper aseptic technique while performing tasks in the ISO 7 and ISO 8 areas to include routine aseptic sampling in the BSC (pulling of samples, EM monitoring).
- Troubleshoot process equipment and interact with maintenance personnel.
- Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors.
- Recognize and report deviations or potential issues immediately to the management team.
- Communicate and report status of equipment maintenance related issues to the area supervisor / manager and assist with actions necessary to resolve issues.
- Perform all job responsibilities in compliance with applicable EHS / GMP regulations, guidelines, policies, company standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
- Demonstrate Company Values
- Patient Focus, Transparency, Respect, and Integrity in every interaction, in every work task, and with every responsibility of the job role. Live Company's Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
- With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks
- Proactively works with senior staff to achieve competency in production operations
- Supports in crossfunctional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution. Primarily these activities are within the production suite, but sometimes require out of suite or offsite work
- Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc)
- By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success
- Transparently participates in investigations that are the result of safety or compliance issues.
- Bachelor's degree in a biological, chemical science, engineering or degree in other discipline if sufficient technical depth has been achieved from professional experience.
- High School Diploma with 2+ years manufacturing production, cGMP experience.
- Previous manufacturing or laboratory experience requiring aseptic or sterile technique required.
- Some mechanical aptitude required in order to operate pumps, scales and PH meters.
- The capability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines.
- Ability to read, understand, follow and comply with technical and written documents (SOPs.)
- Ability to work around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
- Ability to perform calculations using simple mathematical formulas using fractions, percentages and significant numbers. The ability to measure volume and weight.
- Must be able to follow detailed processing instructions, clearly and accurately documenting all necessary batch documentation.
- Basic computer skills required.
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Biopharm Manufacturing Associate - Cambridge, United States - Randstad USA
Description
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena.
Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions.
Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future.
To be recognized as a crucial part to furthering this goal, join this growing team nowlocation:
Cambridge, Massachusetts
job type:
Contract
salary:
$ per hour
work hours: 9 to 5
education:
Bachelors
responsibilities:
As an Associate II (3rd Shift), you will be responsible for setting up the TFF, UFDF, BSC, filtrations, and formulating various Buffers.
You will perform area clearance, and ensure room readiness for the upcoming shift, as well as finishing filtration/bottling/sampling from the outgoing shift.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following:
qualifications:
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
OR
skills:
SOP, MS-WORD, MS-EXCEL, GMP (Good Manufacturing Practice)
Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.
In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
