Job Description
Position Summary
Manufacturing associate I is a hands-on position responsible for executing buffers and media for the upstream and downstream manufacturing process. The candidate will be responsible in the preparation of buffers related to all the manufacturing scale for engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise on pH / conductivity meter, osmometer, weighing scale, filter integrity operation and other related equipment.
Work in a team environment to execute batches and can work independently with minimum supervision.
Essential Duties & Responsibilities
-Prepare buffers and media for Downstream manufactuirng and Upstream manufacturing process respectively.
-Fill out all inventory cards after completion of the preparation activities.
-Participate in monitoring activities for manufacturing related processes.
-Should be able to come in shifts (whenever required)
-pH / conductivity meter, osmometer and scale calibration / verification.
-Filling out GMP batch records.
-Review of the buffers and media batch records.
-Ensure that all the buffers and media batch records are prepared in timely manner.
-Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
-Coordinate the conduction of investigations and corrections for issues found during the media / buffer batch execution process.
-Performs other functions as required or assigned.
-Complies with all company policies and standards.
Position Requirements and Qualifications
Education:
-Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 1-2 years of related experience in the biopharmaceutical industry.
-Previous experience working in GMP and aseptic manufacturing environment.
-Possess knowledge to execute buffer preparation for engineering and clinical batches; familiar with GMP documentation.
Special Skills:
-Ability to work with other team members and independently - good interpersonal skills.
-Good communication skills: verbal and written, good computer and organization skills, detail oriented.
-Basic computer skills, including knowledge of Word, Excel and spread sheet
-Knowledgeable in GMP batch manufacturing documentation.
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. No travel involved.
Employment Type: Contractor
Salary: $ 26.00 32.00 Per Hour
Job Tags
Hourly pay, Contract work, For contractors, Flexible hours, Shift work,