Quality Control Analyst (Microbiology Emphasis)
The primary role of this position is to provide operational support with an emphasis in Microbiology for the Quality Control (QC) cGMP functions, both for laboratory and manufacturing operations. Role will focus on support activities, such as sampling, environmental monitoring and microbial testing, material inspection, and support of manufacturing and laboratory operations.
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:
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.
Operate analytical instrumentation (i.e. HPLC, Bacterial Endotoxin, AES).
Log and maintain all references and standards used to support QC testing.
Participate in the construction and/or revision of SOPs.
Write and update protocols, log books, and checklists.
Develop and qualify Quality Control (QC) finished product test methods.
Coordinate testing with contract laboratories and vendors.
Perform incoming inspection of raw materials and components.
Act as Subject Matter Expert for environmental monitoring and perform environmental monitoring in accordance with all applicable standards.
Support QC functions for cleanroom operations.
SME in execution of all microbiology protocols.
Reviews and verifies analytical and/or microbiological data and reports, ensuring accuracy and consistency.
Train other analysts to perform QC testing and procedures.
Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
Maintain accurate QC lab inventories and order supplies as needed in the lab.
Maintain QC lab which includes routine housekeeping activities.
Receive, distribute, track, and coordinate cGMP samples for testing.
Participate in internal assessments and regulatory audits as required.
Document events, deviations, and laboratory out-of-specification (OOS) investigations. Trouble shoot and problem solve in order to provide possible solutions to problems and issues that may arise.
Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to 5% 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.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Microbiology (preferred), Chemistry, Biology, or other related scientific discipline (microbiology focused), 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, generating associated data packages, auditing data packages generated by others, trending data, and statistical analyses required. Familiarity with executing SOPs in a cGMP environment.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.
Ability to work long (>8 hours) and unusual hours to include third shift, weekends and holidays.
Detail oriented and very organized
Strong verbal and written communication skills
Ability to handle multiple tasks simultaneously
Adaptable to change in the work environment
Ability to work in a fast-paced environment
Ability to work in a team environment, as well as independently
Ability to handle substantial paperwork- keeping it organized, sorted correctly, and traceable.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.