Pharma - Regulatory and Compliance, Quality Assurance

2 weeks ago

Somerset, United States BCForward Full time
Job DescriptionJob Description

BCforward is currently seeking a highly motivated Sr Compliance and Regulatory Specialist for an opportunity in Franklin Township, NJ 08873

Position Description

Job Title: Sr Compliance and Regulatory Specialist

Location: Franklin Township, NJ 08873

Pay Range: $50 - $53

Duration - 3 MONTHS - TEMP TO HIRE

Shift - MON-FRI 8AM-5PM

 

Job Description

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.

• Facilitate and host customer audits at the Catalent Somerset site to ensure compliance with cGMPs, as well as Corporate and site standard operating procedures.

• Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.

• Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure.

• Lead the internal audit program at the site.

• Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed.

• Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.

• Initiate deviations when site procedures are not followed.

• Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.

• Participates in the preparation of Supplier and Customer Quality Agreements.

• Participate in global supplier and regulatory meetings and effectively represent the site.

• Review and approve TrackWise Records as needed acting as a QA Representative.

• Review and revise departmental SOPs as required.

• Comply with Environmental, Health & Safety requirements.

• Other ad hoc duties as assigned.

 

POSITION REQUIREMENTS:

 

Education & Experience:

• A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function

• Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function

Knowledge:

• Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.

• Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.

• Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred

• TrackWise experience is preferred.

• ASQ CQA or relevant Certification is highly preferred

Company DescriptionAbout 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 receivCompany DescriptionAbout BCforward\r
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.\r
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.\r
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.\r
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.\r
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.

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