ESSENTIAL JOB FUNCTIONS
- Supervisor and mentor QA team members, fostering accountability, compliance, and continuous improvement
- Oversee QA training, ensuring employees are equipped with GMP and the necessary skills
- Set performance objectives for the QA team and provide regular feedback and performance evaluations
- Provide QA oversight of quality events, deviations, CAPAs, and OOS Phase II investigations, make key decisions on product quality, compliance, and regulatory conformance, and escalate significant risks to leadership
- Oversight of customer complaint handling
- Review and/or approve methods, procedures, master records, executed records, reports, and protocols employed in the conduct of cGMP activities
- Support planning and execution of internal audits, external audits, regulatory inspections, and supplier audits by preparing documentation, maintaining records, and tracking responses to findings.
- Assist in maintaining a Supplier Management Program
- Contribute to the Quality Management System (QMS) by developing, implementing, and continuously improving SOPs, training programs, and systems
COMPETENCIES
- Leadership skills
- Strong interpersonal, verbal, and written communication skills, including technical writing skills
- Ability to lead projects with minimal supervision required; to work independently and in a team-based environment
- Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving
- Skilled in root cause analysis and implementing effective corrective actions
- High degree of accuracy and strong attention to detail
- Good working computer skills; proficient knowledge of Microsoft Office
WORK ENVIRONMENT
- While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving parts and vibrations. The noise level in the work environment is usually moderate.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, use hands to handle or feel, and reach with hands or arms. The employee is occasionally required to sit, stoop, kneel, crouch or stand for periods of time. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
USUAL WORKING HOURS
- Monday – Friday, 8:00 a.m. to 5:00 p.m.
- Capability to work extended hours if necessary.
TRAVEL
- This position may be required to travel for educational purposes.
REQUIRED EDUCATION/EXPERIENCE
- Bachelor’s degree in a science discipline
- At least 5+ years in a QA function within the pharmaceutical industry, including 2+ years of experience in a leadership role
- Strong leadership abilities with experience mentoring and developing teams
- Previous experience leading inspection readiness and audits
- Strong knowledge of quality systems, deviation/investigation management, risk assessment, and regulatory compliance expectations
- Knowledge of cGMPs or quality regulations, including ICH Q7 and 21 CFR 211 preferred
ADDITIONAL ELIGIBILITY QUALIFICATIONS
- Language skills- must be able to read, record and speak the English language, interpret documents such as directions, instructions, safety rules, and procedure manuals in the English language. Must be able to record written information accurately.
- Reasoning ability- must have the ability to apply common sense and understanding to carry out instructions furnished in written, verbal or diagram form. Must be able to deal with simple problems in an organized and efficient manner.
COMPENSATION AND BENEFITS
- This position is eligible for all full-time benefits including:
- Health Insurance greatly subsidized by the company
- Dental, Life, and Disability Insurance at no cost to employees
- HSA, HRA, and Day Care Assistance Plans
- 401(k) Retirement Plans with Profit-Sharing
- Bonus opportunities
- Generous PTO and paid holidays
- The starting salary for this position is $90,000 per year.
EEO STATEMENT
PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
WORK AUTHORIZATION
Must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship at this time.
OTHER DUTIES
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.