Must have:
- Bachelor's degree (B.S/B.A.) or higher in microbiology, chemistry, or related fields.
- 5 years of relevant laboratory quality assurance experience.
- 2 years of experience in a quality management position overseeing quality assurance and quality control activities.
- Ability to work onsite full-time.
Summary: Candidates in this position are responsible for leading a QA team, implementing the Quality System, and maintaining Quality Records. Incumbents will help identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. The Quality Manager will routinely report on the performance of the Quality System to senior leadership while maintaining and actively working towards improving the Quality System. Essential Duties/Responsibilities
- Manages the Quality Department.
- Oversees all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
- Oversees the internal auditing program to ensure the established techniques are followed and understood; maintains and controls the audit records.
- Responsible for the planning and preparation of customer and regulatory audits.
- Serves as site interface to the Food and Drug Administration (FDA) and other groups conducting audits of the facility.
- Oversees the Management Review process.
- Reports on the performance of the Quality System to senior leadership during the Management Review process.
- Oversees the laboratory proficiency testing program.
- Maintains the list of approved suppliers and subcontractors.
- Maintains accurate and current documentation of the Quality Manual, Quality Procedures, Laboratory Operating Procedures, records, and other documents.
- Creates, revises, reviews, and approves newly written documents and document revisions.
- Identifies and records any problems relating to Quality and the Quality System and initiates corrective action to prevent the recurrence of similar problems.
- Addresses and controls any deviations and/or nonconformities from current procedures and techniques, determines and oversees corrective and preventive measures.
- Conveys, upholds, and reinforces the quality policy and objectives of the laboratory to employees and customers.
- Audits methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
- Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.).
- Serve as site contact for all quality inquiries on analytical reports and related documentation.
- Works with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
- Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines.
- Maintains documentation in accordance with the Quality System, including overseeing the SOP program, document control, and change control.
- Reviews Quality Agreements and works with senior leadership to maintain compliance with the documents.
- Assist senior management in ensuring the company's registrations and accreditations remain current (e.g. FDA, ISO, GDUFA, etc.).
- Exist as a backup for all other Quality Assurance personnel.
Education:
- Bachelor's degree (B.S/B.A.) or higher in microbiology, chemistry, or related fields.
Experience:
- 5 years of relevant laboratory quality assurance experience
- 2 years of experience in a quality management position overseeing quality assurance and quality control activities.
- Must have experience working in a GMP facility.
- Must have experience working in an ISO 17025:2017 accredited facility.
- In-depth knowledge of audits to include FDA, ISO, internal, and customer audits.
- Experience with testing of pharmaceutical, cosmetic, and/or medical device products.
Competencies:
- Adaptable, technical, and attentive to detail. Works well in a team and has the desire to grow their team.
- Capable of maintaining objectivity without undue influence.
- Is open-minded, self-confident, mature, personable, and relates well to people at all levels.
- Able to pass a BG/DS.
- Displays sound judgment and ambition; is quality-focused; displays good communication skills; good implementation and follow-up skills.
- Is comfortable with the goals, values, and philosophy of Infinity Laboratories.
- Must be a detail-oriented, problem-solving, self-initiating individual with strong interpersonal written and oral communication skills.
Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.