The Quality Control Analyst II is responsible for executing QC testing
and related analytical activities supporting product development,
release and stability. This individual conducts routine and non-routine
chemical and physical analyses of raw materials, in-process materials
and drug products according to standard operating procedures. The
Quality Control Analyst II compiles data for documentation of test
procedures that may include stability program testing and formulation
studies, participates in the preparation of investigations, summaries
and reports, and reviews data obtained for compliance to specifications
and reports out-of-trend and/or out-of-specification results. The
Quality Control Analyst II revises and updates standard operating
procedures as needed.
_*_ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other
duties may be assigned.
- Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis,
FTIR, laser diffraction, KF).
- Statistically and critically analyzes data for trending and
reporting into regulatory filings.
- Participates in Laboratory and/or Quality Investigations.
- Monitors equipment and instrumentation used on a daily basis to
ensure proper operation and calibration.
- Participates in the construction and/or revision of SOPs.
- Assists in the writing and updating of analytical test procedures,
protocol, log books and checklists.
- Responsible for identifying and alerting a supervisor of issues on
instruments and/or test executions; makes initial recommendations
for possible solutions and/or corrective actions.
EDUCATION AND/OR EXPERIENCE:
- Bachelor’s Degree in Physical or Chemical Sciences (life sciences)
required.
- Minimum of 2-5 years of experience in a cGMP regulated
environment required.
- Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade
Impactor and Emitted Dose techniques) preferred.
SUPERVISORY RESPONSIBILITIES: none
QUALIFICATIONS:
- Extensive experience with executing QC test methods, generating
associated data packages, auditing data packages generated by
others, troubleshooting instrumentation, trending data and
statistical analyses required.
- Demonstrated ability to lead and/or author investigations to
determine root causes of OOTs and/or OOSs according to cGMP
standards required.
- Ability to troubleshoot and repair analytical instrumentation such
as HPLCs and UPLCs preferred.
- Experience with analytical method development and
validation preferred.
- Familiarity with executing Standard Operating Procedures in a GMP
setting required.
- Chromatography skills using Empower and/or ChemStation required.
- Critical understanding of the importance of documentation and data
traceability required.
- Working knowledge of cGMP’s and their application to Quality
Control required.
COMPUTER SKILLS:
CERTIFICATES, LICENSES, REGISTRATIONS: none required
OTHER SKILLS AND ABILITIES:
- Excellent oral and written communication skills.
- Ability to effectively manage time and prioritize tasks
independently to meet tight timelines and shifting priorities.
- Demonstrates dedication to documentation/data traceability and
strong attention to detail.
- Demonstrates appropriate safety consciousness.
PHYSICAL DEMANDS:
The physical demands here are representative of those that must be met
by an employee to successfully perform the essential functions of this
job.
- Ability to lift up to 20 lbs.
- Ability to stand for long periods of time.
- This position requires minimal travel; average travel for this
position is ≤10% with some variation based upon the demands of the
business imperatives.
WORK ENVIRONMENT:
The work environment characteristics described here are representative
of those an employee encounters while performing the essential functions
of this job.
Ability to work safely and conscientiously in a laboratory environment;
wear appropriate personal protective equipment; communicate with others
in the laboratory to mutually ensure continued safe laboratory
practices.
*To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
above 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.