Senior Associate, QA

InnovaSolutions is immediately hiring for a

As a Senior Specialist, Quality Assurance (Warehouse Operations) you will beresponsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging / labeling operations. This role will provide critical quality support to process to ensure compliant receipt, inspection and release of materials used in cGMP manufacturing operations. You will be essential to Quality floor support of the warehouse and cryogenic facilities. This includes leading the effective resolution of deviations and nonconformances associated with materials, suppliers, and storage.

Your role will partner with Supply Chain / Warehouse, Manufacturing, Engineering, IT (ERP) and Quality Control functions to execute and continuously improve operating procedures that interface with the ERP system such as label inspection, container/closure inspection, retain management and disposition of starting and raw materials. As new products are introduced, the Senior Associate, Quality Assurance (Warehouse Operation) will support the onboarding of GMP materials through participation in risk assessments, Material Review Board, generation of specifications, master data review and supplier qualification activities.

Core Responsibilities.

Execute Quality Assurance procedures for material inspection and disposition, at new Gene Therapy Manufacturing Facility.

Support supplier quality management including change notifications and corrective action requests.

Assist with the onboarding of new GMP materials and suppliers.

Conduct Quality assessment of non-conforming materials and evaluate trends.

Inspect labels, starting materials and fill/finish components before use in manufacturing.

Responsible for writing, revising, reviewing and/or approving documents associated with GMP materials such as SOPs, work instructions, and protocols.

Work cross-functionally to investigate and resolve deviations.

Execute QA review and approval of master data in the ERP system. Verify chain of custody and complete final release of GMP raw materials.

Identify and implement continuous improvement activities to eliminate waste and increase the efficiency and effectiveness of Quality oversight.

Requirements

Minimum B.S. degree; preferably in scientific or engineering field.

Quality experience preferred.

Experience working at a pharmaceutical manufacturing site.

Strong knowledge of GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products.

Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.

Travel may be required up to 5%.Ability to travel to other Boston-area locations for larger team meetings.

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

Qualified candidates shouldfor 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.

Thank you!

[email protected] m

*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.

InnovaSolutions 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).

Founded in 1998 and headquartered in Atlanta, Georgia,InnovaSolutions 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.

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest CertifiedMBECompanies in theNMSDCNetwork (2022)
• Advanced Tier Services partner withAWSand Gold with MS

: https://www.innovasolutions.com /

is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.InnovaSolutions 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 [email protected] m or (770) 493-5588. Please indicate the specifics of the assistance needed.InnovaSolutions encourages all interested and qualified candidates to apply for employment opportunities.InnovaSolutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. §1324b.