Innova Solutions is immediately hiring for a QA Associate / Document Controller I
Position type: Full-time; Contract Duration: 06 Months Location: Athens GA 30601 USA Number of openings: 02
As a QA Associate / Document Controller I, your responsibilities:
Job Duties:
Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation.
Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
Information must be proactively shared across QA and the business including the on-going training of junior team members.
Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations.
Works closely with others to determine root cause and potential preventative/corrective actions.
Ensures support for the timely closure of investigations.
Provides guidance directives regarding remediation activities required to continue production.
Oversees execution of remediation/CAPA activities required to continue production or move a process along.
Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities.
Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.
Ensures all specifications are met and that requirements are completed and acceptable.
Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
Analyzes and reports findings to appropriate departments.
Works closely with others to recognize opportunities for improvement and drive change through the use of BIFI' Quality Systems.
Qualifications:
Bachelors degree in Life Sciences or Engineering.
05 - 07 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.
Strong independent judgment and decision making abilities required.
SAP Experience is required.
Project management experience
Strong knowledge of relevant regulatory guidances.
Demonstrated problem-detection and problem-resolution skills required.
Strong conflict resolution and negotiation skills required.
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills; good interpersonal skills.
Capability to establish good relationships with others who have different values, cultural styles and perspectives.
Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.
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! Ramesh Tummala Lead Recruitment ramesh.tummala@innovasolutions.com
PAY RANGE AND BENEFITS: Pay Range: $28.00 to $30.00 per hour on W2
*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: https://www.innovasolutions.com/
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.
