Position Title: Quality Assurance Specialist II
Work Location: 7555 Gateway Boulevard, Newark 94560-1152
Assignment Duration: 9 months
Work Arrangement: Onsite

Position Summary:
The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience.
Under supervision, the individual will be working in the Product Quality Assurance team, primarily providing quality oversight and support to internal and external drug substance and drug product production and lot disposition.

Background & Context:
Under supervision, the individual will be working in the Product Quality Assurance team, primarily providing quality oversight and support to internal and external drug substance and drug product production and lot disposition. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, MSAT, Facilities, Supply Chain, and Regulatory Affairs.

Key Responsibilities:

• Perform a wide variety of quality assurance activities to ensure compliance with procedures, applicable US and international regulatory requirements for biologic drug substances and drug products.

• Coordinate and perform area approvals and product inspection

• Review documents such as standard operating procedures, master batch records, and packaging and labeling records

• Review executed production batch records and associated documentation, including any deviations related to batch disposition, for internal manufacturing and external CMO

• Perform retain sampling and maintain reserve sample program

• Act as a compliance resource to provide guidance and assistance towards resolution of issues under guidance

• Perform review and disposition of incoming raw materials

• Continuously improve quality operation processes; author/revise existing procedures and forms

• Assist in data verification for regulatory submissions

• Assist with inspection preparation/strategy in internal compliance audits, regulatory agency inspections, or third-party audits

• Update department databases to ensure accurate reporting of quarterly metrics

Qualification & Experience:

• Excellent interpersonal, verbal, and written communication skills

• Uses experience, knowledge, and judgement to resolve simple issues

• Ability to organize and multi-task in a fast-paced environment

• Good working knowledge of cGMP standards applicable to commercial biologics

• Specific vision abilities required by this job include passing a visual acuity test

• Prior experience with regulatory inspections and Veeva is desired

• BA required, preferably in life sciences field

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 43.42/hr.