The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications.

Essential job duties

1. Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
2. Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling
3. Back up for QC analytical instrument maintenance and calibration
4. Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
5. Perform or assist with QC method qualifications, transfers and validations
6. Perform QC method development
7. Perform cleaning validation studies
8. Assist with the evaluation of new equipment and processes
9. Assist in the review of QC data and provide summaries to management as needed
10. Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC
11. Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure

Education, experience, certification and licensures

Required

• Bachelor’s degree in Chemistry or related field
• Minimum 3-5 years’ experience in pharmaceutical industry environment or equivalent combination of education and experience

Preferred

·         Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

1.       Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

2.      Ability to meet deadlines and work under pressure with limited supervision

3.       Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently

4.      Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

5.      Ability to write reports, business correspondence, and procedure manuals

6.      Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations

7.       Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis

8.      Ability to define problems, collect data, establish facts, and draw valid conclusions

9.      Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

10.  Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems

11.   Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.