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QC Supervisor - Stability and Tech Services

Company: Thermo Fisher Scientific Inc.
Location: high point
Posted on: May 3, 2021

Job Description:

Job Description

SUMMARY

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 and timely.

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

regulatory commitments.

* 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 chambers.

* Participate in Change Control processes as needed * Provide data and information in response to external and internal audits/ regulatory

Inspections.

* 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 Corrective/Preventative

Actions (CAPAs)

* 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

employees.

* Provide technical support to analysts and technicians in the lab. Lead and train personnel

in special test procedures, SOPs, equipment, and general laboratory guidelines.

* Perform regular 1-on-1 coaching as well as annual performance evaluations for

subordinates and provide feedback for improvement.

* Participate in ongoing training for the development of managerial and technical skills.

QUALIFICATIONS

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

essential functions.

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 experience,

including 1-2 years of supervisory experience or other applied/ demonstrated leadership experience.

Keywords: Thermo Fisher Scientific Inc., High Point , QC Supervisor - Stability and Tech Services, Other , high point, North Carolina

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