Qc Analyst Jobs

About The Position

Requirements

• Bachelor in a Life Sciences discipline with a minimum of 8 years of experience working in a cGMP QC laboratory OR Masters’ in a Life Sciences discipline with a minimum of 6 years of experience working in a cGMP QC laboratory.
• 2 – 4 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
• Skilled in Instrument qualification, method Validation, Aseptic technique, and cGMP compliant lab experience.
• Strong Writing, Excel, Word and Power point skills.
• Excellent understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP requirement and SOP's.
• Ability to foster a culture of continuous improvement and excellence in the QC laboratory area.
• Outstanding leadership and management capabilities to build, motivate and manage a team.
• Good problem solving and organizational skills.
• Strong written and verbal communication skills in English, with the ability to work cross‑functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

Nice To Haves

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

• Coordinate the QC lab activities to meet production goals, quality and cost objectives.
• Provide support to analyst in troubleshooting QC testing methods and instruments.
• Supervise daily QC activities and ensure schedule is followed.
• Perform analytical, microbiological and raw material dossier review.
• Review all QC forms and logbooks used for daily operations.
• Assist in OOS investigations.
• Assist in instrument qualifications.
• Lead training of QC analyst.
• Execute Method Validation, IPC, CFP, Microbiological and Raw Material Test.
• Author and revise QC lab documents such as SOP, Specifications, Protocols and Reports.
• Set and ensure a regular follow up of the individual SMART objectives in collaboration with the members of his/her team.
• Implement/ Execute the company strategy and organizes the activities within his/her team.
• Measure the performance of his/her team.
• Share relevant information and communicates with his/her team.
• Develop each team member's autonomy and expertise, through training and any other development opportunity mainly.
• Other duties are assigned.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Cross-functional exposure to other areas within the organization.
• 152 hours of paid time off annually + 8 paid holidays.
• Medical, dental, vision and 401K benefits effective day one of employment.
• Tuition Reimbursement.