QC Lab Technician I

Job Description

Job Summary:

• To analyze and/or test under cGMP, raw materials, intermediates and finished products by applying validated or compendia methods.
• Performs/Applies knowledge and skills to diverse reactions.
• Release testing of products per current compendia, regulatory and corporate quality systems, and principles.

Duties and Responsibilities:

a) Key areas of accountability/responsibility:

• Performs analysis in the laboratory with minimal supervision.
• Prepares standards, mobile phases, and reagents.
• Calibrates and monitors laboratory equipment (HPLC, GC, ICP, etc.).
• Analyzes raw materials, intermediates, stability samples and finished products for required tests by various analytical and instrumental methods.
• Performs calculations, collects and prepares data for evaluation.
• Keeps supervisor informed of work status.
• Investigation of OOS results under guidance of senior staff.
• Maintains good documentation practices.

SHE Duties & Responsibilities:

• Display and promote positive safety behaviors at all times; use proper personal protective equipment, appropriate safety tools, equipment and procedures to ensure that self and others go home safe each day.
• Ensure that area and equipment operate at the highest safety levels.
• Ensure that all people in the area (lab techs, quality personnel, maintenance, visitors, contractors, etc.) comply with the safety directives and keep the area neat and clean.
• Ensure incidents are investigated, reported, and risks are assessed in a timely basis.
• Act in such a way that safety awareness & accident prevention are considered in performing all tasks.
• Show leadership by working to SHEQ standards and encouraging colleagues to work to the same standards.
• All employees to be aware of and follow all Client Life Saving Rules.
• Show leadership by working to support Customer Commitments and encouraging colleagues to work to the same standards.
• Support plant and corporate initiatives as outlined in the manufacturing plan.

a) Projects/special assignments:

• Responsibility for correctness of the determined results.
• Work according to SOP’s and Specification sheets. 

Complexity of the Position:

• Demonstrate the ability to learn and perform lab-specific analytical methods.
• Complete analysis on raw materials and finished products within an agreed upon turn around time.
• Ensure SOP’s and specifications are up to date and in compliance with current Compendia and update them if required.
• Perform and document all work associated in adherence with cGMP guidelines.

Education and Experience:

• Bachelor’s degree in a relevant Scientific discipline preferred, associate’s degree required.
• Required Level of Experience:0-3 years of lab experience.
• Experience in Microsoft Office (Outlook, Word, and Excel).

Knowledge, Skills and Abilities:

• Broad/general knowledge of quality control techniques and methods.
• Broad understanding of safety, laboratory hygiene and GMP rules.
• This position is overtime eligible.
• The schedule may be structured with a required overtime component built-in.
• Candidates must be able to work shifts, weekends, overtime (including coverage), and holidays as required.
• All candidates, both internal and external, applying for this position understand that overtime may be required and adjusted based on business needs and to ensure continued safe operations.