ESSENTIAL JOB FUNCTIONS
- Knowledgeable in FDA requirements for quality systems and Good Manufacturing Practices (GMPs)
- Author policy-level standard operating procedures (SOPs) and assist in maintaining Quality Assurance documentation
- Assist in managing document updates, reviews, and approvals within the scope of the Quality Management System (QMS)
- Assist in identifying compliance gaps in support of FDA preparedness
- Initiate, facilitate and/or manage projects to expand, enhance and improve the quality system
- Work closely with Contract Manufacturing Organizations and assist in conducting audits
- Collect and analyze data to identify trends
- Assist in the development, implementation, and evaluation of the performance of processes and programs
- Lead investigations of product and process non-conformances, deviations, and out-of-specification results and develop effective corrective and preventative actions (CAPA)
- Perform and document root cause analysis and risk-based assessments
- Provide training and support to team members
- Perform and document internal audits of production and laboratory processes
- Assist in maintaining a supplier management program
- Assist in and review validation activities
- Participate in regulatory agency (i.e., FDA, etc.) inspections
- Work closely with employees of all levels to maintain and improve the QMS
COMPETENCIES
- Good communication skills, both verbal and written
- Strong technical writing skills
- High degree of accuracy and strong attention to detail
- Excellent data collection and analysis skills
- Working knowledge of tools, methods, and concepts of quality assurance
- Good working computer skills; proficient knowledge of Windows Office
- Leadership skills
- Be self-motivated
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 function 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, 7:30 a.m. to 4:30 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 scientific field
- At least 3+ years of experience in a GMP compliant environment
- Experience working in a QMS
- Experience in working in a pharmaceutical and/or biopharmaceutical industry (or other regulated industry), preferred
- Working knowledge of cGMPs or quality regulations, including ICH Q7 and 21 CFR 211
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, Dental, Life, and Disability Insurance
- 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 $80,000 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.
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.