QA Associate, Clinical Studies

3 days ago

Del Mar, United States BCforward Full time

QA Associate, Clinical Studies

BCforward is currently seeking a highly motivated QA Associate in San Diego, CA 92121

  • Job Title: QA Associate
  • Duration: 3+ months contract
  • Location: San Diego, CA 92121
  • Anticipated Start Date: ASAP
(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)
  • Job Type: Contract (40 hrs. a week)
  • Pay Range: $25hr-$28/hr

(Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

Work Schedule:
MON-FRI 8AM - 4:30PM
ONSITE POSITION. POSSIBLE TEMP TO HIRE IF SALES CONTINUE TO GROW.

Job Description:
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: 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
* Excellent written and verbal communications skills with internal and external customers, peers and managers
* Lead by example according to Client's 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

Business Environment:
* Fast-paced
* Performance Driven
* Customer Focused
* Collaborative and inclusive
* Professional Office Setting
* Confidential Department

Benefits:
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.
This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Interested candidates please send resume in Word format Please reference job code 233556 when responding to this ad.

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