Job Description
Innova Solutions is immediately hiring for a QUALITY ASSURANCE SPECIALIST
Position type: Full-time Contract
Duration: 6 months
Location: Remote / Emeryville, CA
As a QUALITY ASSURANCE SPECIALIST you will:
Job Description
PRIMARY PURPOSE OF POSITION:
The Quality Assurance Specialist Contractor is responsible for supporting activities related to Quality Systems including Document Control, Training, Quality Records Management, Supplier Management, Audits, and Quality Event Management (Deviation, CAPA, Change). This position will support the upgrade implementations and maintenance of the electronic Quality Management System (eQMS), which will be used company-wide for document control, training, and management of Quality events such as deviations, complaints, and CAPAs.
MAJOR DUTIES OF POSITION: - Administer the Document Control program. Support the development of QA systems, Directives, and SOPs.
- Administers the Training Program. Trains personnel and provide technical support.
- Support the implementation and continuous improvement of the eQMS by collaborating on the development of SOPs, protocols, and reports for operations and validation activities.
- Administer the QA archive (controlled documents), including filing/retrieving of records and creation/distribution of copies of archive materials.
- Supports the oversight of Quality Events such as deviations, CAPAs, and change controls, where these events impact Quality Systems they administer (documents, training, records, etc.).
- Maintain records and generate reports for Quality management review.
- Supports internal and external audits. Support the Quality team during regulatory inspections.
- Support the Dynavax Supplier Management Program, including but not limited to qualification, periodic evaluation and/or requalification of new and/or existing Suppliers and Service Providers.
- Support the generation and management of the annual External and Internal Audit schedules employing a risk-based approach.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
KNOWLEDGE AND SKILLS REQUIRED: - Minimum 3 years relevant experience in Quality Assurance in the biotechnology or pharmaceutical industry.
- Experience with an electronic quality management system (e.g., document control/training system).
- Knowledge of FDA regulatory requirements for biologics or pharmaceuticals.
- Must have excellent communication and interpersonal skills and proven ability to establish collaborative relationships and work within a team-oriented environment.
- Must have the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
- Self-motivated and directed; works effectively independently but willing to seek guidance as appropriate.
- Strong technical writing and editing skills.
- Proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
- Ability to sit for prolong periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
- Occasional travel required, as needed.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Preeti Sehgal
preeti.sehgal@innovasolutions.com 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. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
Job Tags
Full time, Contract work, Temporary work, For contractors, Work experience placement, Immediate start, Remote job, Worldwide, Flexible hours,