QA RA Compliance Specialist - BCforward

QA RA Compliance Specialist

BC Forward is currently seeking a highly motivated QA RA Compliance Specialist I in Petersburg, FL 33716

Job Title: QA RA Compliance Specialist

Duration: 6+ months

Location: Petersburg, FL 33716

Job Type: Contract (40 hrs. a week) / Temp to Perm

Pay Range: $25/ Hr - $30Hr. on W2

Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

Start Date: ASAP
Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.

SHIFT - MON-FRI - 8AM - 5PM OR 9AM - 6PM.

Job Description:
* Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
* Provide initial regulatory impact assessment on all change controls as required.
* Liaise with customers to ensure customer requirements are satisfied.
* Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
* Prepare and submit all federal, state and local permits in timely manner
* Interact with Customers and gather information as needed to support registration activities
* Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
* Assist in regulatory/health authority audits collecting information as requested
* Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution
* Prepare APRs in accordance with site procedures and timelines.
* Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
* May author other types of quality system documents as directed or assigned by QA management.
* Other duties as required in support of the client performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow up actions; facilitating and conducting training.
* Assist in complying with any other company and /or departmental objectives as directed by the Group Leader
* Assist in other special projects as assigned

IV. Knowledge Requirements:

Education or Equivalent:
* Bachelors Degree in Science or related field required (Chemistry, Microbiology or Biology);
* A minimum of 3 years related experience in the pharmaceutical manufacturing industry.
* Strong background working with Change Controls and management of change control processes.
* Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.

Knowledge/Skills Requirements:
* Prior regulatory affairs, quality control or quality assurance experience is a must.
* Working knowledge of US application regulations and cGMPs, and FDA Guidance for both.
* Excellent organization skills and extreme attention to detail are a must.
* Excellent oral and written communication skills.
* Motivated, self-started, team player.
* Able to reflect a strong quality work ethic.
* Proven ability to multi-task and demonstrate diplomatic skills.
* Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
* Working knowledge of cGMPs and/or OSHA regulations required.

Benefits:
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.
This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Interested candidates please send resume in Word format Please reference job code 234318 when responding to this ad.