Clinical - QA Associate, Clinical Studies

Medvacon Life Sciences•San Diego, CA

5h•Onsite

About The Position

Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Follows established protocols and work plans. May be assisted by QA Specialists and Sr. Specialists. Comply with divisional and site Environmental Health and Safety requirements.

Requirements

Associate’s degree or equivalent knowledge and experience.
Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
Must be able to use existing procedures to solve routine and non-routine problems
Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials
Recognizes unmet needs within department and business
Must anticipate and identify unmet customer needs.
Be able to proactively address work issues at the individual and team level
Mathematical and scientific reasoning ability
Ability to identify aberrant data and potential quality/compliance concerns escalating to management
Excellent written and verbal communications skills with internal and external customers, peers and managers
Lead by example according to our values and culture
Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment.
Strategy is focused on personal time management and efficiency
Well organized with ability to multitask
Ability to work effectively under pressure to meet deadlines
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
May require the use of a respirator

Nice To Haves

Six Sigma or ASQ certification preferred.

Responsibilities

Responsible for inspection of incoming materials for GMP production
Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)
Reviews production batch records, logbooks and other associated documents
Performs Quality verification of just-in-time labeling activities
Performs document issuance, scanning, filing and archival activities
Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed
Assists in the execution of efficiency improvement projects with guidance
Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines
Ensures gathering of data, investigations and deviations are timely and compliant
Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
Respond and interact with internal and external clients in a professional and timely manner
All other duties as assigned