SUMMARY/OBJECTIVE:
This position supports the R&D scientists and conducts tests to determine quality of raw materials, bulk intermediate, finished products, and cleaning verification/validation samples and ensure compliance with established standards. May perform method development and validation. Conducts routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Supports the Analytical Laboratory Services in the development and maintenance ofthe analytical laboratory and its practices and procedures.
- Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods.
- Develops, conducts, and validates various chemical assays.
- Develops, evaluates, and validates analytical methods for activities such as cleaning verification via HPLC.
- Collects and analyzes routine equipment cleaning verification/validation samples.
- Complies, interprets, and documents data from analytical tests.
- Troubleshoots analytical methods and equipment.
- Prepares Certificates of Analysis and analytical reports.
- Prepares and maintains raw data for review.
- Documents analyses in laboratory notebook, worksheets, or production batch records as applicable.
- Peer-reviews laboratory records.
- Communicates quality or compliance concerns to Line Manager and Senior Management with urgency as applicable.
- Supports Out-of-Specification (OOS) or Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations per internal SOPs.
- Supports environmental monitoring activities as required.
- Complies with Standard Operating Procedures (SOPs), cGMPs, and other regulatory standards as applicable.
- Performs other duties as assigned.
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s Degree in Chemistry or relevant field with a minimum of 2 years of analytical laboratory experience.
- At least 2 years of experience with HPLC method development.
- Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, and ISO.
- Strong background and understanding of USP, EP, other pharmacopeia.
COMPETENCIES/SKILLS:
- Excellent written and verbal communication skills with ability to give internal and external presentations.
- Hands-on skilled coordination and dexterity and attention to detail
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software.
- Excellent organizational and communication skills.
- Read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods.
- Legible Handwriting
- Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
- Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.
SUPERVISORY RESPONSIBILITIES:
None
SCHEDULE:
5 days a week on site, M-F
SALARY:
$80,000 - $100,000
WORK ENVIRONMENT:
This job operates in an office/lab setting.
PHYSICAL DEMANDS:
Capable of lifting 50 lbs. occasionally preferred.
TRAVEL:
Travel will be required less than 10% of the time, domestic and international