Job description

Title: Team Lead, QC Chemistry

Reports to: Manager, QC Chemistry

Department: Quality Control

Location: Indianapolis

FLSA Status: Exempt

Position Overview:

This position includes analytical testing duties as well as oversee duties. Supervise the QC analytical chemistry laboratory operations including product testing and data review/approval. Responsible for ensuring laboratory personnel adhere to SOPs, business plan, and operate in a safe environment.

Major Position Activities & Responsibilities:

• Oversight, training, and coaching of analytical laboratory contract staff. This includes test scheduling and assignment of analytical duties. Also assists in the supervision of other Analytical laboratory staff.
• Assure operations in the lab are in compliance with cGMPs and Company SOPs/policies.
• Responsible for the analytical testing of finish product, raw materials, stability samples, engineering, and in-process materials.
• Responsible for the analytical laboratory’s Environmental, Health, and safety compliance.
• Responsible for the laboratory’s adherence to the business plan.
• Review and approval of analytical test data
• Communication of analytical operational issues to affected departments or as directed by QC’s

Management. This includes effective communication between Chemistry shifts.

• Represent the Analytical Laboratory in a technical expert capacity on special studies and validations when required
• Lead non-conformance and OOS investigations within the laboratory.
• Support manufacturing process control and process improvement projects.
• Performs special projects and other duties as assigned.
• As a part of the employee’s job requirements, the employee may be required to handle hazardous chemicals including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training

Scope:

• 50% lab testing and data review
• 50% oversight of laboratory analysts

Background Qualifications:

• B.S. degree with a major in chemistry, or related scientific discipline with expertise in analytical chemistry
• Minimum of four years of experience in the pharmaceutical industry in QC or a related area.
• Demonstrated leadership ability in the Pharmaceutical Industry preferably in an analytical laboratory.
• Ability to communicate at all levels in a pharmaceutical operation. Good interpersonal skills are a must.
• Knowledge of QC systems operations, GMP testing/manufacturing environment expertise, analytical method validation and chemistry analytical techniques.
• Ability to perform physical and environmental requirements of the job
• Ability to travel to vendors or contract laboratories as required

Page 1 of 1 JD-10133-01

INDY

6925 Guion Road

Indianapolis

IN

Document Detail 3/13/2020

1

Type: JD

Document No.: JD-10133[01]

Title: Team Lead, QC Chemistry Job Description

Owner: KABERLE Karla Aberle

Status: CURRENT

Effective Date: 13-Mar-2020 Expiration Date: 13-Mar-2023

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 10 hour shift
• Day shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Indianapolis, IN 46268: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• What is your desired salary?

Education:

• Bachelor's (Required)

Experience:

• HPLC: 3 years (Preferred)
• UPLC: 3 years (Preferred)
• Chromatography: 3 years (Preferred)
• Pharmaceutical: 4 years (Preferred)
• GMP: 2 years (Required)

Work Location: One location

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