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Clinical QA Associate, Clinical Studies
Job Location:
Job Location:
San Diego, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
30 May 2026 (30+ days ago)
Posted:
Application Deadline:
18 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
This is an on-site contract opportunity. 3 months with potential extension
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.
II. Essential Functions:
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
III. Position Requirements:
Education or Equivalent: Associates degree or equivalent knowledge and experience.
Experience: Six Sigma or ASQ certification preferred.
Knowledge/Skills Requirements:
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 CSD-JD-QA Associate Clinical Supplies v1.0
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 Physical Requirements:
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
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.
II. Essential Functions:
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
III. Position Requirements:
Education or Equivalent: Associates degree or equivalent knowledge and experience.
Experience: Six Sigma or ASQ certification preferred.
Knowledge/Skills Requirements:
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 CSD-JD-QA Associate Clinical Supplies v1.0
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 Physical Requirements:
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
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Manager
About Company
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