Job description

Pharmaceutical Quality Assurance

Position Summary:

The QA Project Manager 1 is responsible for leading efforts involving a variety of essential day to day work functions in the Quality Department, including, but not limited to specific Quality functions, providing oversight and assisting Operations personnel with validation, calibration, maintenance, and general Quality oversight duties.

Essential Duties & Responsibilities:

The QA Project Manager must be proficient in all Quality functions including but not limited to:

Exert daily quality oversight over warehouse activities and documentation in compliance to quality system and regulations (e.g., 21 CFR Part 210 & 211, SOPs, COPs, etc). Examples include:

• Perform independent secondary inbound and outbound inventory verifications (for product located in all Sentry storage environments)
• Review warehouse shipment and receipt paperwork for errors prior to filing
• Quality oversight of general electronic inventory system and client order process
• Reviews Facility Walkthrough Inspections (Weekly, Monthly, Quarterly) for adherence to SOPs
• Reviews Pest Control Inspections
• Download temperature data from primary Building Management System (BMS) and secondary temperature-monitoring system and generates temperature trending reports
• Supports internal, client and regulatory audit/inspection process
• Assists in drafting and revising SOPs
• Assists with Sentry training program and filing
• Assist with Sentry labeling and packaging activities
• Oversee and assist with validation and calibration activities (e.g., initiating validation change controls, executing software validation testing, validating equipment, temperature data logger placement/downloads, etc.)
• Support Quality oversight of facility and equipment Preventative Maintenance (PM) program, including:
• Review and approve all equipment and facility PM inspection documentation
• Maintain and keep all forms up-to-date and organized
• Additional Duties as assigned by manager

Competencies:

• Self-motivated and require little direction or supervision.
• Ability to multi-task.
• Excellent attendance and punctuality during normal business hours
• Effective time management when dealing with and working under time constraints and other pressures associated with performing all aspects of this job.
• Ability to organize work.
• Detail oriented.
• Knowledge of quality, compliance and training requirements for product safety.
• Knowledge of GMP regulations and reporting requirements.
• Working understanding of the principles of (PMP) Project Management Professional as delineated by (PMI) Project Management Institute.
• Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
• Ability to understand basic job functions and relate those to other job categories within the company.
• Excellent verbal and written skills with all levels of the organization and ability to develop rapport with other members within the company.
• Drives results through personal initiative and perseverance.
• Excellent teamwork skills. May act as mentor to other team members and interface with other departments to help define and drive improvements the business’ compliance and strategy.
• Capacity workload planning and prioritizing.

Education and/or experience:

BA or BS in a science/technical field and with some previous QA/QC experience in the pharmaceutical, biotech, or other FDA-regulated industry or equivalent combination of education and experience.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit and taste or smell. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to cold/freezing conditions. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; heat and vibration. The noise level in the work environment is within OSHA regulations.

Other Skills and Abilities:

• Able to maintain regular and predictable attendance.
• Able to establish and maintain effective relationships with those contacted within the line of work.

Job Type: Full-time

Pay: $50,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Compensation package:

• Yearly pay

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• The nature of the work at Sentry BioPharma Services requires that applicants submit to a background check and drug screening prior to hiring. Will there be a problem acquiring satisfactory results? (Yes or No)
• What is your desired salary range?

Work Location: In person

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