job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. As a passionate group of people leading the charge for better health options, our longtime partner puts patients first. They know that every one of our employees is essential to achieving this goal. If you want to work in a challenging environment that sets the stage for growth in your career, join our team today!
location: Sunnyvale, California
job type: Contract
salary: $48.00 - 50.50 per hour
work hours: 9 to 5
responsibilities: General Position Summary/Purpose:
Performs and maintains QA programs, systems, policies, process, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical and commercial drug substance (DS) or drug products (DP) manufactured at CMOs. Key Accountability /Core Job Responsibilities:
- Reviews and approves master batch records, labels, specifications, protocols and other manufacturing documents of drug substances and/or drug products in compliance with both US FDA and international health agency requirements.
- Reviews and approves executed manufacturing batch records, analytical data, reports and associated documentation, including any deviations and investigation reports related to material disposition. Follow-up activities include tracking corrective and preventive actions (CAPA) as needed.
- Ensures that executed batch records are complete and that all associated records are obtained and compliant.
- Communicates with CMOs as necessary.
- Reviews change control requests to ensure compliance with company procedures, cGMP, and other applicable regulations.
- Archives (scan, file and storage) batch-related documents.
- Performs person-in-plant (PIP) function during manufacturing campaigns of DS and/or DP at CMOs.
- Provides progress against weekly deliverables and prepares quality metrics as needed.
- Creates, revises and reviews SOPs (as required)
- Provides training to new employees. Qualifies QA personnel when requested by the supervisor.
Excellent working knowledge and understanding of GMP related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R&D a plus.
- Detail-oriented with excellent review skills of production records for lot disposition. Ability to work effectively in a team environment with great organization skills.
- Experience in clinical/commercial API and/or drug product is highly desired.
- Practical working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials and commercial drug product.
- Ability to independently analyze and reconcile simple to moderate issues.
- Must be an individual with proven initiative and demonstrated accountability who is comfortable working in a fast paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e. Microsoft Office products).
qualifications: Education, Qualifications and Requirements:
- Minimum BA/BS degree in Biological sciences, Chemistry, or related field.
- 7+ years of pharmaceutical experience in a GMP quality (QA/QC) environment.
skills: SOP, CAPA, Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.