Directly supervises laboratory personnel in the area of
scheduling lab testing and reviewing of
analytical data for Raw Materials, Finished Products,
In-Process, Stability and non production
samples, including Cleaning Validation, Verification, Vendor
Evaluation and Qualification
samples in a manner consistent with established standards.
Provides support through a leadership role within the QC
Department to ensure that services and
support to the manufacturing operations are efficient, effective
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Ensure that the QC lab samples are tested in a timely manner
to ensure on-time delivery
for the site, and also ensure on-time testing of stability
samples and review to meet
* Provide batch disposition for Raw materials, In-Process and
Finished Product results in a
manner consistent with cGMPs, policies, and procedures.
* Provide oversight of the stability program to include but not
limited to: sample inventory
management, scheduling stability samples for on-time testing,
scheduling stability data
for on-time review and reporting, tracking & trending of
stability data, issuing and
revising stability protocol, enrolling new samples in the
stability program, issuing final
stability reports to support APRs, recommending expiration dates
for bulk and packaged
products and scheduling routine PM/calibration for all the
* Participate in Change Control processes as needed * Provide
data and information in response to external and internal audits/
* Monitor production schedules and new product transfers for
products that need to be
included in the stability program.
* Serve as Lead Investigators or provide support to Lead
Investigators to conduct a broad
spectrum of activities including troubleshooting, writing QC lab
investigations related to
testing to identify root causes and implementing appropriate
* Work collaboratively with other members of lab management to
formulate and establish
operating procedures and Work Instructions for QC employees.
* Formulate and maintain Quality Control goals and objectives
complementary to corporate
and plant policies and goals.
* Interpret and adhere to all company policies and enforce
safety regulations for
* Provide technical support to analysts and technicians in the
lab. Lead and train personnel
in special test procedures, SOPs, equipment, and general
* Perform regular 1-on-1 coaching as well as annual performance
subordinates and provide feedback for improvement.
* Participate in ongoing training for the development of
managerial and technical skills.
To perform this job successfully, an individual must be able to
perform each essential duty
satisfactorily. Additionally, an individual must uphold the
standards of conduct of the company,
which include confidentiality, cooperation, and respect for
people and property. 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
EDUCATION AND EXPERIENCE:
Bachelor's Degree in Chemistry, Microbiology, Biology,
Biochemistry or related field, with at
least 8 years of related experience in an analytical laboratory
setting, or a combination of advanced degree and related
including 1-2 years of supervisory experience or other applied/
demonstrated leadership experience.