Position Summary:
Quality Assurance Specialist provides Quality Assurance (QA) support and oversight for QC laboratory operations through review of laboratory data and documentation to ensure GMP and date integrity compliance. This position works closely with Quality Control (QC) laboratory staff, Quality Engineering and QA personnel to support investigations and other laboratory quality activities. Success in this role requires a strong understanding of laboratory testing principles, attention to detail, and the ability to apply data integrity concepts when reviewing and approving laboratory data.
Responsibilities: Essential Duties
- Administrates, facilitates and maintains site quality management systems to ensure they are efficient, effective and compliant to applicable cGMP, regulatory requirements and expectations, and the Company's Quality System policies and procedures.
- Supports regulatory inspections, customer and/or Third Party Audit.
- Provide direction, training, and mentoring for company personnel on policies in compliance with current GMP's and corporate policy.
- Ensuring that the quality system standards imposed by customers are not overlooked, yet do not compromise or conflict with internal B. Braun Requirements.
- Understands and ensures regulatory compliance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
- Requires basic knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
- Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other peers.
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with direct supervisor, peers and subordinates.
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
- Bachelor's degree required or equivalent combination of education and experience.
- 02-04 years related experience required.
- Applicable industry/professional certification preferred.
- Regular and predictable attendance
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
- Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
- Occasionally:Reaching upward and downward, Push/pull
- Frequently:Stand, Sit
- Constantly:N/A
Activities:
- Occasionally:Finger feeling, Push/pull, Reaching upward and downward
- Frequently:Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing
- Constantly:Hearing - ordinary, fine distinction, loud (hearing protection required), Talking - ordinary, loud/quick
Environmental Conditions:
- Occasionally:N/A
- Frequently:N/A
- Constantly:N/A
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.
- Noise Intensity:Moderate
- Occasionally:N/A
- Frequently:N/A
- Constantly:Office environment
Salary Range: $85,300 - $95,300
