Sr. Quality Associate I/II/Principal Associate, Compliance
Company: Grifols
Location: Clayton
Posted on: March 18, 2023
Job Description:
The Quality Compliance Auditor may be assigned various duties
and responsibilities including but not limited to:
- Auditing, data analysis, coordination and/or review of purchase
specifications, standard operating procedures, quality agreements,
failure investigations, change control requests, review of
manufacturing or testing reports, etc.
- The incumbent requires minimum supervision, and is a
technically competent professional who has demonstrated excellent
organizational and leadership skills, and capable of independently
developing and implementing solutions for a variety of quality
related objectives.
- He/she must have excellent written and verbal communication
skills, and may lead multi-discipline teams on projects of medium
to high complexity.
- The employee communicates with employees at all levels,
including other Grifols sites, suppliers/customers, and regulatory
agencies.
- He/She demonstrates consistent application of technical
knowledge in executing assignments, and develops solutions for
defined problems.
- The employee may train other employees. As appropriate, this
employee may serve as authorized delegate for the department
supervisor.
- The primary responsibilities of the position include the
following: plan, schedule, lead, and execute, or otherwise
participate in routine and directed internal audits utilizing
knowledge of US and foreign regulations, guidances, and industry
standards for pharmaceutical and medical device manufacturing;
review/analyze data, prepare and review reports; follow-up on audit
observations and/or verify corrective actions associated with
internal and external audits or other sources, through
collaboration with manufacturing and QA/QC for improvement of
Quality Systems, etc.: support site regulatory and customer audits,
perform audit follow-up activities by requesting responses,
tracking the status of corrective actions.
- The incumbent may also lead/participate in supplier management
external audits and other supplier quality activities; author,
edit, and/or publish SOPs, purchase specifications, and other
documents as directed using company prescribed computer software
and systems.
- The position also performs routine surveillance of current
regulatory changes and expectations and incorporates them into the
working operations of the company.
- Perform other duties as assigned by Quality Compliance
management. Required Knowledge, Skills and Abilities: The candidate
must possess in-depth knowledge of FDA, EU, PIC/S, and ICH cGMPs,
and must have demonstrated application of such regulations and
guidances in robust Quality Systems. Excellent communication skills
(written and verbal) are required. The successful incumbent must
have demonstrated a high degree of organization and follow up skill
set. Required Experience/Education: Sr. Quality Associate I,
Compliance (M8) / Sr. Quality Associate II, Compliance (M9),
Principle Quality Associate (M10): BA/BS required preferably in a
STEM (science, technology, engineering, or mathematics) curriculum
and 5 years (M8), 6 years (M9), or 8 years (M10) of relevant
experience. *Must possess current ASQ auditor certification:
Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA)
or equivalent auditor certification from a recognized professional
certification authority. Must possess adequate proficiency in the
use of Word and Excel computer software. Working knowledge of SAP
functionality is desirable. Experience/Equivalency: Depending on
the area of assignment, directly related experience or a
combination of directly related experience and/or competencies may
be considered in place of the stated competencies. Work Hours: This
position is routinely scheduled to work Monday through Friday
during dayshift. Work on other shifts or days may be required
and/or assigned for specific periods by management, including the
requirement to travel during non-dayshift hours for work-related
projects/duties. Overtime may be required as needed. Work is
performed in an office and a laboratory/manufacturing environment
or warehouse. Exposure to biological fluids with potential exposure
to infectious organisms. Exposure to occasional extreme cold below
32 in production areas. Exposure to electrical office and
laboratory equipment. Personal protective equipment required such
as protective eyewear, garments and gloves. Work is performed
sitting or standing for 2-4 hours per day. Frequent hand movement
of both hands with the ability to make fast, simple, movements of
the fingers, hands, and wrists. Ability to make precise coordinated
movements, of the fingers to grasp and manipulate objects. Light to
moderate lifting and carrying objects with a maximum lift of 35lbs.
Occasionally walks, bends and twists neck and waist, may reach
above or below shoulder height. Frequent foot movements. Color
perception/discrimination and near vision correctable in one eye to
20/30 and to 20/100 in the other eye. Able to communicate complex
information and ideas so others will understand; with the ability
to listen to and understand information and ideas presented through
spoken and written words and sentences. Performs tasks by following
a set of written or oral instructions/procedures. EEO
Minorities/Females/Disability/Veterans
Keywords: Grifols, Raleigh , Sr. Quality Associate I/II/Principal Associate, Compliance, Other , Clayton, North Carolina
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