Job Description

Please rush your resumes at  PRIYA T PRIYA.T@INFOTREEGLOBAL.COM or feel free to reach me at 201-762-4370. Manufacturing Associate/Lab Associate Roles MUST HAVE REQUIREMENTS • They need to be able to work 12 hour shifts (5:45 AM to 6:15 PM OR 5:45 PM to 6:15 AM) • They need to be able to work weekends (See work week schedule below which alternates 3 days and 4 days each week) • Fresh science grads from local universities, or people with some GMP experience and attention to detail

OBJECTIVES: (Briefly summarise the overall purpose of the position. Objectives should be written in 3 – 4 bulleted statements). • Perform and document daily manufacturing operations according to SOP’s in a cGMP environment • Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) • Execute validation protocols • Create or revise cGMP documents

ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified). • With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels. • Perform basic trouble shooting • Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems • Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks. • Executes batch records and validation protocols under supervision/direction of others • Author and review equipment use logs • Performs inventory transactions in SAP • Performs data entry into LIMS • Accountable for completing assigned trainings within required timeline and actively participate in training activities. • Stock production and cleaning supplies • Perform cleaning/sanitizing production rooms and equipment • Other duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.) Preferred combination of education and experience: • Bachelor’s degree in Science or Engineering; or • Associate’s degree in science-related area and 1 or more years of relevant experience; or • High school diploma or GED and 3 or more years of relevant experience. • Experience in a regulated environment preferred

Knowledge, competencies and skills: • Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred • Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred • Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus • Prior experience with lab equipment a plus • Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding. • Must have excellent written and oral communication skills • Must be team and detail-oriented and able to work in a fast-paced environment. • Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT) • Must be able to read and understand English

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily • Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials • Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations. • Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations • Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations • Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time • Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time • Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time

OTHER REQUIREMENTS: • Must have the ability to work assigned shift (day or night) • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection • On rare occasions, travel may be required to offsite meetings or training event  

Qualifications null Additional Information

• All your information will be kept confidential according to EEO guidelines.