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PDS Tech Inc Sr. QC Scientist, Days B in San Diego, California

PDS Tech, Inc. is seeking Sr. QC Scientist, Days B

Key Responsibilities:

  • Plan and meet QC schedules to fit the business daily needs

  • Resolve any obstacles by providing procedure or product performance technical guidance to the QC Lab

  • Exercises judgement within defined procedures and policies to determine appropriate action

  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner

  • Provides training to QC personnel and assures training is up to date for the team

  • Provides feedback of QC personnel training and performance to upper management

  • Interacts with employees, outside customers, and functional peer groups at various management levels

  • Leads and participates in cross-functional teams

  • Summarize data to monitor/trend product performance

  • Deliver weekly, monthly, and quarterly metrics

  • Support quality initiatives such as process and product characterizations that lead to continuous / cost improvements

  • Responsible for meeting deadlines under a tight timeline and changing priorities

  • Provides feedback on troubleshooting and lab investigations to other QC personnel

  • Owns high-risk Non-Conformances/ Deviations / CAPAs

  • Recommend and execute test procedure updates

  • Performs tasks related to QC functional responsibilities such as, stability, validations, sample retention program, customer complaints, inventory maintenance, and continuous improvement efforts

  • Provide administrative and technical support services during quality assurance audits

  • Reviews manufacturing batch records for accuracy, completeness, and GDP

  • Always complies with Good Lab Practices (GLP) and Good Documentation Practices (GDP)

  • Embodies cultural values and aligns daily actions with department goals and company culture

  • Other activities as deemed necessary by the QC management team

Minimum Requirements/Qualifications:

  • High school diploma (or equivalent)

Personal attributes:

  • Proficient in Microsoft Excel and Word

  • Effective written and oral communication skills

  • High attention to detail, highly organized, and strong documentation skills

  • Ability to be self-motivated, proactive, accountable, and flexible

  • Ability to work well under pressure, handle multiple tasks/projects and meet deadlines

  • Sets stretch goals and links them to strategic outcomes and business deliverables

  • Comfortable with ambiguity

Non-Negotiable Hiring Criteria:

  • Experience in an FDA regulated and/or cGMP environment required

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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