Lab Tech II

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.