QA Specialist I

Title: QA Specialist I
Location: Scarborough, ME - 04074
Duration: 8 Months, Till year end

The position of Quality Assurance Specialist I is within our Infectious Disease Business Unit located at Scarborough, Maine. In this role you will, under basic direction and supervision, provide support for product quality assurance, process improvements and all quality system programs at the Scarborough Site. This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES: The following activities may be assigned as applicable:
Review production batch records (DHRs) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assure they have been addressed and resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Write Standard Operating Procedures (SOPs) as necessary
Assist in testing of complaint samples and stability samples and report results out of acceptance limits
Initiate Quality Incidents (QI)
Provide backup to other Quality Specialists
May organize the long-term stability program and be responsible for administering the sample retention program
May administer or support the site s current electronic Document Control System (eDCS)
May administer or support the site s current electronic Quality Incident and CAPA tracking system.
Other duties may be assigned.

Basic Qualifications | Education:
Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a scientific or technical area or the equivalent combination of education and experience.
1+ years in Quality Assurance role or similar support for manufacturing.

PREFERRED QUALIFICATIONS:
Prior experience in a Quality Assurance role or similary support role in the medical device industry

COMPETENCIES:
Knowledge of spreadsheet software and word processing software
Ability to follow procedures and accurately document results
Ability to understand the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to write routine reports and correspondence
Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations
Attention to detail