Senior Quality Control Compliance Specialist Jobs

Escalates program risks to senior stakeholders and management, when appropriate

Coordinates with key stakeholders to ensure that the provided documentation is sufficient to meet process requirements

Manages and maintains recordkeeping documentation to ensure an audit ready environment

10+ years of experience, preferably some experience in transformation roles

Well-developed listening skills and a strong ability to engage with colleagues at all levels

Strong interpersonal skills with ability to influence and negotiate with stakeholders, including a proactive and 'no surprises' approach in communicating issues/requests/escalation

Strong problem-solving skills with experience in Root Cause Analysis.

Interacts effectively with business partners to communicate and resolve issues. Understands business requirements of the other functions.

Master/PhD in Chemistry, Biochemistry or related science with a minimum of 5-10 years’ experience in a cGMP (analytical or biology) environment.

Prior experience working in a GMP analytical laboratory with demonstrated proficiency in complex laboratory analysis.

Understanding of compliance requirements and regulatory expectations.

Experience with a broad range of analytical techniques applicable to monoclonal antibodies, including (cell-based) bioassays, qPCR and ELISA methods.

The Specialist, QA Systems and Compliance will report to the Sr. Manager, Quality Systems and Compliance

Executes supplier audits and implements Astellas requirements where applicable.

Perform other support responsibilities as requested to support Quality and Regulatory oversight activities.

Proven ability to manage multiple projects while maintaining quality

Strong interpersonal skills with reputation for collaboration with colleagues

Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls.

Hands-on experience with the management of Quality System Processes such as Deviation, CAPA, and Change Controls required.

Provides guidance/coaching to less experienced colleagues.

Manufacturing, Laboratory, quality, technical or engineering experience within biotech of pharmaceutical industry.

Demonstrated skills in analysis and problem-solving.

5 years of diversified experience in a clinical trial, pharmaceutical or biopharmaceutical manufacturing environment.

Assist with updating reports, data entry and required documentation.

1+ years of experience in general office administration.

A comprehensive and highly competitive benefits package

Work from home and still be part of a team!

Professionally handle and direct all phone interactions in a timely and courteous manner.

Respond to emails, chats, and texts in a timely manner in accordance with department SLAs within the CST Organization.

Experience with risk management facilitation is required.

Assist/conduct training for risk management, investigations, change controls, auditing, supplier management programs, and other processes as needed.

Formal Risk Management training is recommended.

Conduct audits of suppliers to ensure they comply with their procedures, regulations, and Polaris Pharmaceuticals, Inc. requirements.

Develop familiarity and keep current with cGMP and applicable regulatory requirements as needed.

Excellent written, verbal, and communication skills.

An equivalent combination of education and experience.

A bachelor’s degree in civil engineering, Surveying, or Transportation-related Engineering and one year civil engineering or surveying experience.

Experience in material testing, quality control/compliance or construction project inspection.

Strong knowledge of mathematics and highway construction procedures and practices.

Experience reading, interpreting and applying technical manuals, specifications, contract plans and other guides.

Preferred certifications in CATII, CCT and CMDT.

Demonstrates professional communication and interpersonal relationship skills including consultative approaches and relationship management

Manage customer relationship and expectations during course of complaint investigation and resolution process

Bachelor's Degree in related field, plus minimum of 5 years relative experience complaint handling or quality compliance required

Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), or related regulated environment required

Advanced knowledge of Medical Device Reporting regulations, and regulatory reporting regulations

Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing

Manage customer relationships and expectations during the course of complaint investigation and resolution process

Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required

Excellent written and verbal communication skills and interpersonal relationship skills

Demonstrated problem-solving , critical thinking, and investigative skills

Full knowledge and understanding of client policies, procedures, and guidelines relevant to quality compliance

Good knowledge of medical terms and human anatomy

Must have good meeting management and communication skills to keep conversations focused and productive.

Coordinate with Third Party Risk management to ensure PCI compliance needs are being addressed and tracked appropriately with third party vendors.

Primary responsibilities of the Information Security PCI Compliance Program Manager include the following:

Draft policies/procedures that govern the security of DISH PCI data across the enterprise with a specific focus on compliance requirements.

Partner with security teams to identify and analyze security requirements to align with PCI compliance standards.

Lead security enhancement projects focused on new or changing PCI compliance requirements.

Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results

Report OOT/OOS results and other deviations to area management.

Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.

Participate in executing method validations and/or classified areas qualifications.

Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.

Demonstrate good communication skills, both verbal and written, at all levels and across various functions.

Quality Assurance, Internal Auditing, Quality Compliance Management or related experience

Support compliance gap management activities e.g. compliance risk management- Identifies risks to the division and resolutions to address compliance gaps.

Help management of near miss program

Provides Quality System Body of Knowledge expertise and support to organization.

Lead in the implementation of assurances, process controls, and CAPA related systems designed to meet or exceed internal and external requirements.

B.S. in Engineering / Business / Operations discipline or equivalent, plus 3+ years of experience in a similar field.

Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various

Controls) and TruVault (Document Management System)

Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56,

A minimum of 2-year experience in pharmaceutical, consumer products, or FDA Regulated

Experience of the overall product development process

Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities

Owns the implementation of change controls to ensure compliance with regulatory requirements and company policies.

B.S. degree in life sciences or Engineering with 2 years relevant experience in biopharmaceutical based GMP environment.

Ability to meet required timelines and skilled to escalate issues appropriately when necessary.

Excellent written and verbal communication skills, with the ability to effectively communicate complex information to both technical and non-technical audiences.

Excellent problem-solving skills, with the ability to think critically and make sound decisions.

Supports implementation of CAPAs may include authors new/revise Standard Operating Procedures, Protocols / Summary Reports / Plans for QC.

Strong knowledge of cGMP regulations and quality management systems

Assist the Quality Manager with assigning and reviewing the documentation received from other departments related to new and revised controlled documents

Train, with the QA/RA Manager, all internal employees on cGMP procedures and maintain training records and documentation as needed

Assist QA/RA Manager with the organization of Quality partner on-site audits

Assist QA/RA Manager with organization, maintenance, and tracking of quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.

Maintain Excel tracking logs and assist QA/RA Manager in evaluating trends

Experience with Blue Mountain, Maximo, or other equipment maintenance management system

Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner

Write and revise equipment and software related documents (user requirements specifications, qualification/validation protocols, etc.)

Work with QC, Facilities, IT, and QA to ensure equipment and associated software is managed in accordance with governing procedures

Excellent communication and collaboration skills

Experience using or managing analytical lab equipment (pH meters, balances, HPLCs, etc.)

· Coordinate with the compliance management to ensure filing dates are met for HMDA.

· General knowledge of overall mortgage lending process; prior mortgage, lending or related industry experience.

· Provide responsive, courteous, and knowledgeable service to Branches and internal departments.

· Complete knowledge of various applicable regulations, specifically: TCPA, RESPA, UDAAP, CAN SPAM, SAFE ACT, TRID, FCRA

· Flexible to work in an ever growing and changing environment with demonstrated analytical skills.

· Basic math skills and strong verbal and written communication skills.

Six years of full-time work experience in any field may be substituted for the required baccalaureate degree.

A maximum of 120 semester hours may be combined with experience to substitute for the baccalaureate degree.

30 to 59 semester hours credit will substitute for one year of experience towards the baccalaureate degree.

60 to 89 semester hours credit will substitute for two years of experience towards the baccalaureate degree.

90 to 119 semester hours credit will substitute for three years of experience towards the baccalaureate degree.

120 or more semester hours credit will substitute for four years of experience towards the baccalaureate degree.

Experience in authoring Chemistry and Bioassay investigations is preferred

Knowledge of General laboratory operations, Instrument and Software, Quality Events

Ability to think critically and demonstrate troubleshooting and problem-solving skills

Strong written and oral communication skills as well as very strong organizational skills

Knowledge of industry standards and guidelines

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including: