Nucrogene Inc.  is a rapidly growing pharmaceutical company engaged in R&D and manufacturing of generic medicines and Over the counter products, located in Branchburg, New Jersey. Nucrogene is recruiting  Internships/CO-OP for highly motivated and self-starter individual who is close to finish/finished  their undergraduate/master’s degree program or suitable candidates in Quality Assurance. Applications are accepted starting from 25^th September 2020 through until the position are filled.

Initial and ongoing training of Quality Assurance procedures and relevant tasks will be provided by Nucrogene Quality Assurance (QA) team,  up on selection of the candidate.  Quality Assurance intern is responsible to perform in-process and finished product tests, load stability samples, perform cleaning verification of process rooms, review and approve Protocols, Procedures (SOPs), and quality related documents. He/she follows and adheres to current Good Manufacturing Practices, Good Laboratory Practices (cGMPs, GLP etc.) to meet quality requirement. Qualified candidates will be expected to work upon training either independently or as a team to achieve company goals and initiatives.

Key responsibilities:

• Supports the development and maintenance of Quality Systems as appropriate.
• All the QA related functions required have to be performed and carried out as per established company standard and procedures and assure that manufacturing/production is according to cGMP regulation.
• Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents.

The typical tasks/activity performed as the production floor QA are listed here but not limited to :

• Review and approve manufacturing batch record, protocols, and SOPs.
• Executed Batch Record review and resolution of comments/issues.
• Perform review of data collected under approved test methods and perform investigation/change controls.
• Support in root-cause analysis and product impact assessment for investigations.
• Providing required approval for production activity and make appropriate entries in respective batch manufacturing records/MMR.
• Verify raw material and components prior to usage as required and checking and monitor the dispensing/weighing process.
• Check cleanliness and provide usage approval of equipment and production rooms in production department namely granulation, Tableting, Encapsulation, Coating, and Packaging.
• Logbook maintenance on daily and calendar basis
• Perform and collect in-process samples e.g. for individual blend sample for uniformity, and composite samples and submit it for QC testing.
• Perform calibrations, preventive maintenance and repairs, as needed on instrumentation.
• Assist in quality control stability testing.
• Prepare and maintain stability records and summaries.
• Modify and validate analytical procedures to meet quality control needs.
• Conduct all quality control chemical tests.
• Perform other duties as assigned.
• Supports regulatory inspections and customer audits.

Qualifications

• Minimum Bachelor’s Degree with major in Chemistry/Biology, Pharmacy, Pharm. D., Master’s Degree in Chemistry or related scientific discipline.
• Working or practical knowledge of the following: Process equipment used in manufacturing  generic medicine and over the counter products, HPLC, UV, Dissolution, Karl Fisher (KF) and other analytical instrumentation is an  advantage but not compulsory .
• Basic understanding of cGMPs, GLP and compendia procedures where applicable (i.e., USP, NF, BP, etc.)
• Strong leadership skills with the ability to thrive in a high throughput environment.
• Proficient with Microsoft Office – Word, Excel and Power point .
• Ability to effectively interact with others.
• Experience on basic laboratory practices required.
• Requires sound communication skills both verbal and written and ability to work successfully in a team environment.

Candidates who receive an offer will be required to go through a background check and drug screen/medical evaluation before being hired by Nucrogene.

Location:

185 Industrial Pkwy # E

Branchburg, NJ 08876

Phone: 908-255-4921

www.nucrogene.com

Nucrogene Inc. is a rapidly growing pharmaceutical company engaged in R&D and manufacturing of generic medicines and over the counter products, located in Branchburg, New Jersey. Nucrogene is recruiting Internships/CO-OP for highly motivated and self-starter individual who is close to finish/finished their undergraduate/Master’s Degree program or suitable candidates in Analytical R&D. Applications are accepted starting from 25^th September 2019 through until  the positions are filled.

Initial and ongoing training of product testing procedures and relevant lab tasks will be provided by Nucrogene AR&D team, up on selection of the candidate.  Analytical Chemistry intern is responsible to perform analytical testing of raw materials (used in generic medicines), in-process, finished product, stability samples, cleaning verification/validation, packaging component, and process validation samples following Analytical Methods, Protocols, Procedures (SOPs) and company policies. He/she follows and adheres to current Good Manufacturing Practices, Good Laboratory Practices (cGMPs, GLPs, etc.) to meet FDA requirement. Qualified candidates will be expected to work upon training either independently or as a team to achieve company goals and initiatives.

Key responsibilities:

• Perform testing of raw materials, in-process, finished product and/or stability samples including dissolution, assay, content/blend uniformity, particle size distribution, and other tests according to the analytical methods, USP, procedures in a GLP environment.
• Analyze and interpret test results.
• Analyze samples using appropriate instrumentation such as HPLC, UV, IR, Karl Fisher KF, pH, etc. Process and report the analysis results using the instrument specific data processing software.
• Document all activities in a legible manner following established formats and good documentation procedures.
• Follow all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Nucrogene Safety and Housekeeping requirements.
• Identify and troubleshoot problems with instrumentation and analytical preparations.
• Prepares and maintains proper analysis documentation, including summarized test data and procedures.
• Develops a basic understanding of production processes and an ongoing proficiency with all analytical test methods related to product specifications.
• Operates in accordance with all safety procedures and SOPs at all times.

Qualifications

• Minimum Bachelor’s Degree with major in Chemistry, Pharmacy, Pharm. D, Master’s Degree in Chemistry or related scientific discipline.
• Working or practical knowledge of the following: HPLC, UV, Dissolution, Karl Fisher (KF) and other analytical instrumentation is advantage, but not compulsory
• Basic understanding of cGMPs and compendia procedures where applicable (i.e., USP, NF, BP, etc.)
• Proficient with Microsoft Office – Word, Excel and Power point
• Ability to effectively interact with others.
• Experience on basic laboratory practices required.
• Requires sound communication skills both verbal and written and ability to work successfully in a team environment.

Candidates who receive an offer will be required to go through a background check and drug screen/medical evaluation before being hired by Nucrogene.

Application for consideration, please send your resume to info@nucrogene.com

Location:

185 Industrial Pkwy # E

Branchburg, NJ 08876

Phone: 908-255-4921

www.nucrogene.com