QA Associate

QA Associate


Job ID: 10241215

San Diego, CA, US

Scientific

Associate Degree

Full Time, Temporary

$33.00 /HR

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

San Diego, CA, US

$33.00 /HR

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Scientific

Associate Degree

First Shift (Day)

Job details

Job Title: QA Associate
Location:  San Diego, CA- ONSITE
Duration: 3 months with temp to perm
Pay: $33.00 /HR 
Shift: MON-FRI 8AM – 4:30pm.

Position Overview:
• 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.

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

Position Requirements:
• Education or Equivalent: Associate’s 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
• Excellent written and verbal communications skills with internal and external customers, peers
and managers
• Lead by example according to the clients 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

Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies 

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay and service bonus plans

  • Group-rate insurance options available immediately upon hire*

 

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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