Lab Tech II

Lab Tech II

Location

Irvine, California

Category: Scientific

Salary

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Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Target PR Range: 19-25/hr DOE

Job Description – 100% Onsite

• Understand Regulations and business processes required to maintain Laboratory Data Integrity.

• Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements

• Responsible for the timely completion of chemical/laboratory testing.

• Ensure that all test equipment is used and maintained correctly.

• Ensure all in-process sampling and testing is completed on time.

• Maintain up-to-date, complete and precise records of all tests performed.

• Adhere to cGMP requirements.

• Assist in the resolution of quality problems as required.

• Develop/update in-house laboratory procedures as appropriate.

• Support the transfer of new products.

• Adhere to and supports all EHS & E standards, procedures and policies

• Support the qualification of new laboratory equipment

• Knowledge in HPLC, Gas chromatography, Capillary electrophoresis, UV analysis

• Able to work in an environment where respirator is required to be worn during production for at least 4 hours.

• Position requires constant body movement such as lifting, carrying equipment during environmental monitoring, pushing carts, doors.

• Able to accommodate weekend and holiday work as required by the manufacturing schedule.

• Participate in method transfers and validations as needed.

• Authoring and review of documents such as protocols, reports, test methods, SOPs.

• Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results

• Support the qualifications of new laboratory equipment.

• Responsible for daily activities such as waste disposal, glasswasher, autoclave runs

• Able to maintain accurate inventory records of toxin during usage.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with internal and applicable regulatory requirements.

Qualifications

• Bachelor’s Degree in Sciences, with a minimum of three (3) years of lab experience.

• Experience using HPLC analytical methods, general chemistry is essential for Chemistry Lab.

• Experience in lab investigations, CAPA, Change Control

• Experience working in a GMP regulated environment

• Ability to articulate clearly when dealing with colleagues, peer groups and managers.

• Proven ability to work independently and autonomously when required.

• Attention to detail.

• Ability to plan and schedule workload.

• Ability to work well under pressure and consistently deliver results while demonstrating an action- orientated approach to overcome obstacles.

• Relevant industry experience preferred.

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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