Chemist-CChemist-C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist-C will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level. Chemist-C will function as a mentor and assist in training new recruits.
Responsibilities:
Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training. Perform troubleshooting and investigations under the direction of a supervisor. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of Analytical documents as required. Active involvement in training and qualification of newly hired chemists. Be a role model and mentor to lesser experienced analysts in the team.
Qualifications: Skills & Requirements
- Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
- Ability to learn quickly and decision making skills
- Attention to detail and documentation
- Proficient in working with Empower and LIMS.
- 2-4 years of experience with handling Out Of Specification investigations.
Education & Experience:- Minimum BS within Scientific field
- BS with Chemistry is one of the subjects would be preferable
- Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing
- 3 years QC experience in Generic Pharmaceutical industries would be preferable
Benefits:- Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
- Dental Benefits with three dental plan options through CIGNAVision Plan with two plan options through VSPLife Insurance, Basic Life and AD&D and Supplemental Life Insurance
- Disability Insurance, Voluntary Short-Term Disability and State Disability
- Long-Term Disability (LTD), State (short term) disability – where applicableFSA (Flexible Spending Accounts) – Both Health Care & Dependent Care AvailableHSA (Health Savings Account)401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
- Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
- Critical Illness and Accidental Insurance
- Legal and Identity Theft Insurance
Paid Time Off: Paid vacation, PTO, Holiday
Compensation MinUSD $85,000.00/Yr. MaxUSD $90,000.00/Yr.
Physical Requirements: FIELD - While performing the duties of this job the employee is required to:
- Work in a temperature controlled office environment or travel via vehicle or commercial transportation
- While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment
- Position requires some degree of travel for business purposes
- Employee may use computer, phone, copier and other office equipment in the course of a day
- Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus
Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
