QC Specialist - GMP , Raw Material , Preventative Maintenance

Submission for the position: QC Specialist - GMP , Raw Material , Preventative Maintenance - (Job Number: 170972)In labs and health care facilities worldwide - HERE WE AREPPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP.

PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a QC Specialist, you will provide support of analytical equipment maintenance and calibration program for the Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. You will ensure activities occur in an efficient and cGMP compliant manner while fostering the customer vision and values while working onsite at a major pharmaceutical customer facility.

Responsibilities:

Provide support and oversight of laboratory equipment PM/calibration program to ensure on-time completion, including completion of lab work orders in computerized maintenance management system

Serve as a liaison between customer and vendors to ensure lab equipment maintenance activities are scheduled and coordinated to meet laboratory needs

Review raw data and results from contract laboratories for raw materials testing

May author, review, and approve data, SOPs, qualification plans, protocols and reports as needed

Reviews analytical data and related notebooks as specified by Standard Operating Procedures (SOPs).

Evaluates data to ensure compliance with analytical methods, customer criteria and Good Manufacturing Practices (GMP)

Performs non-routine and complex data reviews ensuring scientific soundness and method validation

***This is a non-lab based position

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We are looking forward to receiving your application. A member of our talent acquisition team will review your application and if interested, you will be contacted for an interview.

In labs and health care facilities worldwide - HERE WE AREPPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP.

PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a QC Specialist, you will provide support of analytical equipment maintenance and calibration program for the Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. You will ensure activities occur in an efficient and cGMP compliant manner while fostering the customer vision and values while working onsite at a major pharmaceutical customer facility.

Responsibilities:

Provide support and oversight of laboratory equipment PM/calibration program to ensure on-time completion, including completion of lab work orders in computerized maintenance management system

Serve as a liaison between customer and vendors to ensure lab equipment maintenance activities are scheduled and coordinated to meet laboratory needs

Review raw data and results from contract laboratories for raw materials testing

May author, review, and approve data, SOPs, qualification plans, protocols and reports as needed

Reviews analytical data and related notebooks as specified by Standard Operating Procedures (SOPs).

Evaluates data to ensure compliance with analytical methods, customer criteria and Good Manufacturing Practices (GMP)

Performs non-routine and complex data reviews ensuring scientific soundness and method validation

***This is a non-lab based position

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We are looking forward to receiving your application. A member of our talent acquisition team will review your application and if interested, you will be contacted for an interview.

Qualifications

Education and Experience:

Bachelor's degree in Analytical Chemistry, Chemistry, or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 5 years pharmaceutical/biopharmaceutical industry) or equivalent combination of education, training, & experience.

Preferred Experience:

Experience with deviations, OOS, investigations, IQ, OQ, and PQ

Experience with US and EU pharmacopeias

LC, GC, FTIR, Dissolution, and KF

Knowledge, Skills and Abilities:

1 years of laboratory equipment Preventative Maintenance (PM)/calibration experience required

Knowledge of analytical methodologies such as chromatography (LC, GC, FTIR), dissolution, Karl Fisher (KF) and applying/interpretation of GMP requirements required

Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections

Knowledge of MS Office, Maximo, Trackwise, and QDOCCs a plus

Expert knowledge of SOPs and Federal Regulations to include GLP and GMP

Expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs

Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

Strong verbal and written communication skills

Strong attention to detail

Ability to train staff

Ability to deal with multiple and changing priorities

Ability to provide clear and concise feedback and/or documentation of results

Ability to work in a collaborative team environmentWorking Environment:

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

*LI-NW1

Qualifications

Education and Experience:

Bachelor's degree in Analytical Chemistry, Chemistry, or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 5 years pharmaceutical/biopharmaceutical industry) or equivalent combination of education, training, & experience.

Preferred Experience:

Experience with deviations, OOS, investigations, IQ, OQ, and PQ

Experience with US and EU pharmacopeias

LC, GC, FTIR, Dissolution, and KF

Knowledge, Skills and Abilities:

1 years of laboratory equipment Preventative Maintenance (PM)/calibration experience required

Knowledge of analytical methodologies such as chromatography (LC, GC, FTIR), dissolution, Karl Fisher (KF) and applying/interpretation of GMP requirements required

Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections

Knowledge of MS Office, Maximo, Trackwise, and QDOCCs a plus

Expert knowledge of SOPs and Federal Regulations to include GLP and GMP

Expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs

Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

Strong verbal and written communication skills

Strong attention to detail

Ability to train staff

Ability to deal with multiple and changing priorities

Ability to provide clear and concise feedback and/or documentation of results

Ability to work in a collaborative team environmentWorking Environment:

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

*LI-NW1

Submission for the position: QC Specialist - GMP , Raw Material , Preventative Maintenance - (Job Number: 170972)