QC Chemist Senior

Unifin SAS • Rochester, NY

16d

About The Position

Reporting to the QC Supervisor - Finished Products, JOB SUMMARY: This position performs routine analyses as required. Performs method development and validation, from design to execution, with some supervision. Manage projects with moderate input. May independently manage the activities of others. Implement technical improvements to laboratories quality systems. Provide technical resources for laboratory and mentor less experienced employees[BB1] as needed.

Requirements

• B.S. in Microbiology[BB1] Chemistry with minimum of three (3) years’ experience in an FDA regulated laboratory OR
• B.S. in life sciences with five (5) years’ laboratory experience
• Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
• Experienced in method development and validation.
• Competency and demonstrated skill with chromatographic techniques (HPLC, GC, chiral separation) required and/or familiarity/competency with spectroscopic techniques (MS, UV/Vis, FTIR), physical characterization and/or dissolution.
• Ability to evaluate data, perform trend analysis, identify potential issues, propose and implement solutions.
• Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating, and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
• Advanced Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates.
• Advanced Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)
• Intermediate PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace.
• Must demonstrate visual acuity, color recognition, finger dexterity.
• The ability to read, write and communicate in English.

Responsibilities

• Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPscGMPs.
• Execute protocols, experiments as written.
• Reviews and approves laboratory data.
• Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation.
• Ensures an adequate supply of test materials are available to perform daily testing.
• Maintains and updates training records in a timely manner.
• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
• Develops and implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery.
• Monitors the effectiveness of their training efforts and modifies approaches to ensure achievement of learning objectives.
• Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.
• Assists in effective implementation of new procedures by assisting Supervisor/Manager in design and delivery of training to employees.
• Ensures documentation of training is retained as required by departmental procedures.
• Performs method development and validation, from design to execution, with some supervision.
• Seeks opportunities to improve existing methods.
• Leads investigations, proposes solutions, and implements corrective action with minimal supervision.
• conducts and writes laboratory investigations with minimal supervision.
• Proactively identifies, communicates issues & proposes/implements solutions.
• Recommends and assists in implementation of improvements to lab procedures and processes.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees