Compliance Specialist

Position Title : Production -Compliance Specialist

Work Location : Summit West NJ, 07901 (50% OnSite)

Duration : 12 Months

Work Schedule : Need to be flexible

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.

Summary:

The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi?use sites through interaction with internal team members and peer?level 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 multi?tasking 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.

Working Conditions (US Only):

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.

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $55.00/hr.