Position: QA/QC Specialist
Job Location: US-TN-Memphis
Overview
Under limited supervision and with a solid understanding of science and technology,
monitors Quality Control activities and develops and manages quality improvement
initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and
adhered to by staff for the company’s North American operations. This position is
responsible for ensuring proper QC of finished product and raw materials including
stability and other experimental studies as necessary. Conducts investigations and
audits, prepares reports, and follow-up on CAPAs to ensure implementation and
effectiveness. Supports the Quality Director with maintaining the Quality Management
System and general administration of documentation for the QMS.
Responsibilities
Support the organization in monitoring the compliance of laboratory
testing, manufacturing, and clinical research, and ensuring continued
effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP,
GMP, and QSR requirements.
Represent the Quality unit on cross-functional process improvement
project teams.
Prepare, maintain, analyze, and present data related to the quality or
analytical systems as necessary.
Plans and organizes all of the QC activities performed by the quality
department and advice/support operations with laboratory equipment
and QC processes.
Ensures maintenance of Specimen Inventory Databases and
reference materials, including cell cultures and stock validation
Supports new method and instrument QC development and
Validation of procedures, equipment and software as needed
including authoring SOPs/Work instructions etc.
Audits/reviews documentation to ensure all equipment is calibrated,
maintained and serviced as required
Assists with the control of Quality Management system records
Lead and/or support internal audits, client audits, supplier audits,
and regulatory audits including, but not limited to: audit scheduling,
audit preparation, audit execution, audit response/resolution, and
audit follow-up.
Assist in integration efforts and ensure a consistent approach across
all company sites wherever possible.
Participate in the general Quality Department oversight activities and
other duties as assigned.
Communicate effectively with internal personnel, as well as external
customers and suppliers as needed.
Collaborate effectively and positively within department and all other
company departments.
Represent department and the organization favorably and in
accordance with established Company standards.
Follow all company safety policies & other safety precautions within
the work area.
Perform miscellaneous duties as necessary and requested by the
Quality Director or other management
Works to Oxford Immunotec’s Company Values at all times.
Qualifications
PhD with 0-2 years of experience or Bachelor’s degree with 5-7
years of experience in a scientific discipline
3-6 years of Quality experience in laboratory setting preferred
CAP/CLIA or medical device environment a plus
Strong knowledge of scientific principles concepts
Exercises sound judgement regarding selecting techniques,
methods, and acceptance criteria for results
Effectively communicates with employees at all levels of the
organization and various departments
Good working knowledge of MS programs
Experienced in working to GLP and Quality Management principles
Strong attention to detail and Quality commitment
High standards of mathematics and writing ability
Conscientious, thrives in high pressure work, and demonstrates
strong initiative
PHYSICAL DEMANDS:
The physical demands described within the Position Responsibilities section of
this job description 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 be independently mobile. The employee is also required to
interact with a computer, and communicate with peers and co-workers. Minimal
travel required including international travel.
Oxford Immunotec, Inc. is an Equal Opportunity
Employer/Male/Female/Disability/Protected Veteran.
