Job description

Job Description

Title: QC Analyst- weekends - 1st & 2nd shift

Reports to: Supervisor, Chemistry Lab

Department: QC Chemistry

Location: Indianapolis

Position Overview:

Technical entry level position responsible for analytical testing of finished product, raw materials, stability and special test requests. Position also requires analytical testing in support of protocols related to method transfers, method validations, laboratory investigations, and instrument qualifications.

Major Position Activities & Responsibilities:

• Responsible for adhering to the Environmental, Health and Safety program.

• Perform routine analytical testing for in-process and finished products.

• Perform routine analytical testing for raw materials, special test requests, laboratory investigations, and instrument qualifications according to validated methods.

• Perform common laboratory procedures such as pH, weighing on analytical balances, glassware prep, equipment calibrations, and peer review of test parameters and reagent preparations.

• Support manufacturing process control & process improvement projects.

• Assist in the execution of protocols for method transfers, method validations, stability studies, and cleaning validations.

• Review of analytical test procedures as required.

• Performs routine lab maintenance, special projects, and other duties as assigned.

• As a part of the employee’s job requirements, the employee may be required to handle wastes 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:

• 5% Executing protocols for method qualifications, method validations, and qualification of new instruments.

• 5% Revising SOPs and ACMs for the chemistry lab as directed.

• 10% Laboratory Maintenance duties

• 80% Individual contributor as bench analyst

Background Qualifications:

• BS in chemistry or related discipline with a minimum of one year of experience in the pharmaceutical industry.

• Must have familiarity with cGMP in testing/manufacturing environments preferably in pharmaceuticals.

• Working knowledge of Waters Empower 3 chromatography software desired. Experience with

UV/VIS spectrophotometry, FTIR Spectrophotometry, and HPLC/GC chromatography highly desired.

• Knowledge of bio-analytical and chemistry analytical techniques.

• Ability to communicate at all levels in a pharmaceutical organization. Good interpersonal skills are a must.

INDY

6925 Guion Road

Indianapolis

Job Type: Full-time

Pay: $24.00 - $30.00 per hour

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 are your salary requirements?

Education:

• Bachelor's (Required)

Experience:

• HPLC: 1 year (Required)
• UPLC: 1 year (Preferred)
• Liposomal: 1 year (Preferred)
• Chromatography: 1 year (Preferred)
• Electronic lab notebook: 1 year (Preferred)
• GDP: 1 year (Preferred)

Shift availability:

• Day Shift (Required)
• Night Shift (Required)

Work Location: One location

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