Quality Control Analyst

Job Title: Quality Control Analyst

Duration: 6 Months

Location: Camarillo CA

Qualifications:

• Bachelor's Degree in Chemistry or related field and 5 years related work experience;

OR

• Master’s Degree in Chemistry or related field and 3 years related work experience;

OR

• PhD in Chemistry or related field and 1 years related work experience

• Experience working in cGMP or GLP pharmaceutical industry environment

• Willing to work flexible hours (nights and weekends), as-needed (overtime eligible)

Responsibilities:

• Perform complex testing and data evaluation, such as HPLC, ELISA, etc.

• Troubleshoot equipment issues promptly and communicate resolutions to management

• Participate in or assist with test method validations

• Evaluate data for trends

• Support and/or investigate OOS events by performing thorough root cause analyses, assessing potential product impact, and implementing appropriate CAPAs

• Interact with outside departments including attending meetings, providing updates, etc.

• Coordinate testing performed at outside testing labs, raw materials, etc.

• Maintain a detailed and accurate recording of activities and results

• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries

• Perform risk assessment as needed

• Write/revise test methods, standard operating procedures, etc.

• Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures

• Support equipment upkeep

• Prepare and order supplies, as necessary

• Enter data into relevant data management systems and perform tracking and trending of data. Compile data and provide/present data summaries to management

• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry

• Collaborate with cross-functional departments to coordinate testing, scheduling needs, and prioritization

• Lead departmental projects and participate in cross-functional teams, including continuous improvement initiatives and new customer project teams

• Lead the stability program, including management of test points, reporting of data, and investigations of out of specification or aberrant stability results