What are the responsibilities and job description for the Quality Assurance Specialist position at Primary Talent Partners?
Primary Talent Partners has a Quality Assurance Specialist opening for a client in Berkley, CA. This is a 12 month contract. This role is onsite in Berkley, CA. Must be local and a permanent resident (US Citizen, GC Holder) NO C2C
Role: Quality Assurance Specialist
Location: Berkley, CA
Type: onsite
Duration: 12 months, possible extension
Pay Rate: $45.00-$55.00 per hr W2
Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records). Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management.
Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.
Skills & Qualifications (education, experience):
Bachelor’s degree in a scientific/ technical field.
Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
• Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process. Previous work in Quality Assurance (e.g., release) preferred.
• Proven ability as a team player and leader.
• Excellent interpersonal skills
• Must be able to listen and understand the opinions and
perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
• Ability to work both independently and team environment.
• The ability to multitask and support changing priorities
• Strong written and oral communication skills
• Ability to assess, investigate and resolve deviations.
• Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
• In depth knowledge of GMP
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Role: Quality Assurance Specialist
Location: Berkley, CA
Type: onsite
Duration: 12 months, possible extension
Pay Rate: $45.00-$55.00 per hr W2
Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records). Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management.
Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.
Skills & Qualifications (education, experience):
Bachelor’s degree in a scientific/ technical field.
Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
• Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process. Previous work in Quality Assurance (e.g., release) preferred.
• Proven ability as a team player and leader.
• Excellent interpersonal skills
• Must be able to listen and understand the opinions and
perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
• Ability to work both independently and team environment.
• The ability to multitask and support changing priorities
• Strong written and oral communication skills
• Ability to assess, investigate and resolve deviations.
• Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
• In depth knowledge of GMP
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
Salary : $40 - $56
