Compliance Specialist

Compliance Specialist

BCforward is currently seeking a highly motivated Compliance Specialist in Summit, NJ

Job Title: Compliance Specialist

Duration:12 months(possibility of extension for right candidate depending on performance)

Work Schedule: Need to be flexible to come onsite min 50% as required by manager

Location: Summit, NJ

Pay Range: $55- $58/ Hr. on W2

Purpose and Scope of the Position

The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multiuse sites through interaction with internal team members and peerlevel customers as well as external service providers. The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small-scale projects to complete departmental objectives.

Required Competencies- Knowledge, skills, and abilities

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multitasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Ability to organize and present data and findings clearly.
• Possess experience with investigation

Education and Experience:

• Required BS in Engineering or Science related discipline w/minimum 4 years experience OR MS w/2 years experience in GMP environment/regulated industry
• 5-7 years experience in a pharmacopeia compliance related discipline preferred.
• 5-7 years' experience with troubleshooting complex laboratory equipment.
• Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
• Excellent computer skills including knowledge of equipment data quality systems.
• Strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

Duties and Responsibilities

1) Historical Performance Review:

• Execute the historical performance review (HPR), a periodic review of equipment performance and use.
• Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
• Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
• Identify and recommend actions to take because of HPR findings.
• Write deviation and perform investigation per internal procedure.
• Track HPR recommendations and remediation actions.

2) Ensure ECQ Departmental Compliance:

• Participate in revisions to departmental procedures to ensure compliance.
• Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.

3) Compliance Projects:

• Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
• Lead projects both small and large in scope required to keep equipment or the department in compliance.

4) Ensure Equipment Compliance:

• Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. Provide guidance to the team if changes are required.
• Perform gap analysis on existing equipment and technologies to ensure compliance.
• Review new equipment and technologies as it comes to site to ensure compliance.

5) Regulatory Responsibilities:

• Assist in the preparation for both internal and external audits.

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

Environmental Conditions:

• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

Must Haves:

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

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.

Interested candidates please send resume in Word format Please reference job code 237142 when responding to this ad.

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