Quality Control Analyst
The primary role of this position is to provide operational support for the Quality Control (QC) cGMP functions, both for laboratory and manufacturing operations. Role will focus on support activities, such as sampling, material inspection, and general laboratory testing/support.
Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies’ standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Perform incoming inspection of raw materials and components.
2. Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration. Identify and alert Supervisor of issues on instruments and/or test executions; make initial recommendations for possible solutions and/or corrective actions.
3. Operate analytical instrumentation (i.e. HPLC, Bacterial Endosafe, pH meter)
4. Participate in authoring and/or revising of SOPs and forms.
5. Write and update protocols, log books, and checklists.
6. Develop and qualify Quality Control (QC) test methods.
7. Coordinate testing with contract laboratories and vendors.
8. Receive, distribute, track, and coordinate cGMP samples for testing.
9. Perform environmental monitoring in accordance with all applicable standards.
10. Perform QC functions for ISO 7 and ISO 8 cleanroom cGMP manufacturing operations.
11. Assist in the execution of microbiological/chemical testing.
12. Review and verify analytical and/or microbiological data and reports, ensuring accuracy and consistency.
13. Train other QC Analysts to perform QC testing and procedures.
14. Ensure that suitable written records and work is performed in accordance with cGMP and company procedures.
15. Maintain accurate QC lab inventories and order supplies as needed in the lab.
16. Maintain QC lab which includes routine housekeeping activities.
17. Participate in internal assessments and regulatory audits as required.
18. Document non-conforming materials reports (NCMRs), deviations, and laboratory out-of-specification (OOS) investigations. Troubleshoot and problem solve in order to provide possible solutions to problems and issues that may arise.
19. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
20. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to 10% of the time between facilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Familiarity with batch production records (BPR) and attention to detail.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and two to four years of related experience in a cGMP environment; or equivalent combination of education and experience. Experience with executing QC test methods (preferably endotoxin, bioburden, sterility, and environmental monitoring, pH, chemical ID testing), generating associated data packages, reviewing/auditing data packages generated by others, trending data, and statistical analyses. Experience in executing SOPs in a cGMP environment. Familiarity with use of basic to advanced metrological equipment preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, QMS System, and Excel.
• Detail oriented and very organized
• Strong verbal and written communication skills
• Ability to handle multiple tasks simultaneously
• Ability to function in a flexible work environment
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line