Sr. QC Analyst

Innova Solutions is immediately hiring for a Senior Quality Control Analyst

Position type : Full-time Contract position 6+ months

Location : Bothell, WA

Pay Range : $40 / hr-$50 / hr

PRIMARY RESPONSIBILITIES

Performs routine and non-routine testing with expert proficiency and general QC laboratory work for release of Direct Raw Materials to support Seagen’s clinical development and / or commercial products in a GMP testing environment.

Principal Responsibilities

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Performing sample testing for raw material release testing
• Analyzing and compiling data and preparation of reports
• Reviewing assays / data for compliance to specifications and reports abnormalities
• May require lifting / moving heavy objects
• Supporting / managing the daily activities of the lab (responding to RUSH requests, starting raw material batches, assigning of assays)
• Support Release of raw material lots, CoA generation and approval
• Creating and revising standard operating procedures (SOP’s, Specifications, and Test Methods) and other documents as needed
• Identifying and leading continuous improvement projects
• Supporting special projects for analytical problem solving
• Participating in the qualification and validation of test methods
• Troubleshooting laboratory or system anomalies
• Authoring and owning deviations, CAPAs and Change Controls
• Method or system development and / or optimization.
• Training other personnel
• Serving as SME for Test Methods or other areas of expertise
• Providing oversight for programs, specific to job function
• Representing QC in cross-functional teams
• Weekend, Holiday, overtime, and off-hour work may be required as needed to support manufacturing.

Expected Qualifications

• Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience)
• Broad experience with Microsoft Office products
• Be highly organized with an attention to detail
• Strong data interpretation / analytical skills
• Strong troubleshooting skills
• Strong knowledge of GMP compliance
• Strong technical writing and communication skills
• Experienced in lab equipment (pH meters, balances, pipettes, HPLC's / plate readers, automated titrators, spectrophotometric instrumentation, etc.)
• Experience authoring or revising Standard Operating Procedures
• Familiarity with Change Control
• Participation in Laboratory Investigations
• Ability to keep order of multiple projects / tasks

Preferred Qualifications

• 4+ years of experience working in a GMP laboratory
• Participation in Laboratory or Out of Specification Investigations
• Experience or working knowledge of compendial methods / monographs as it applies to raw material testing

Candidates must have good communication skills and great attention to detail.

Thank you!

PAY RANGE AND BENEFITS :

Pay Range* : $40 / hr-50 / hr

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS : Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion.

Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions :

• One of Largest IT Consulting Staffing firms in the USA Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website :

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.