Planet Pharma
Quality Control Operations Analyst I
Planet Pharma - Norton, Massachusetts, United States, 02766
Work at Planet Pharma
Overview
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Overview
Job Description
Overview: The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization.
This position is onsite and will be primarily located in Norton, MA. There may occasional responsibilities at a secondary location in Cambridge, MA.
Key Responsibilities (including but not limited to): •Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, following established SOPs •Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics •Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations •Accurately record experimental data and observations in compliance with GxP standards. Participate in the review of data commensurate with experience. •Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements •Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance. •Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability. •Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective the companies goals •Pursue ongoing training and development to deepen expertise in QC analytical techniques and regulatory compliance.
Qualifications: •Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field •0 to 2 years of experience in a GMP/GLP regulated laboratory environment, with exposure to pharmaceutical or biotechnology industries preferred •Understanding of analytical techniques and their application in raw materials, in-process testing, release, and stability studies is preferred •Strong documentation skills and attention to detail, with an unwavering commitment to quality and compliance •Basic awareness of regulatory guidelines relevant to pharmaceutical QC (GMP, GLP, ICH) is desirable •Effective communication and teamwork skills, with the ability to work collaboratively across functions •Capable of working under supervision and following detailed instructions
Pay ranges between $22-28.45/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Overview: The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization.
This position is onsite and will be primarily located in Norton, MA. There may occasional responsibilities at a secondary location in Cambridge, MA.
Key Responsibilities (including but not limited to): •Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, following established SOPs •Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics •Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations •Accurately record experimental data and observations in compliance with GxP standards. Participate in the review of data commensurate with experience. •Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements •Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance. •Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability. •Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective the companies goals •Pursue ongoing training and development to deepen expertise in QC analytical techniques and regulatory compliance.
Qualifications: •Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field •0 to 2 years of experience in a GMP/GLP regulated laboratory environment, with exposure to pharmaceutical or biotechnology industries preferred •Understanding of analytical techniques and their application in raw materials, in-process testing, release, and stability studies is preferred •Strong documentation skills and attention to detail, with an unwavering commitment to quality and compliance •Basic awareness of regulatory guidelines relevant to pharmaceutical QC (GMP, GLP, ICH) is desirable •Effective communication and teamwork skills, with the ability to work collaboratively across functions •Capable of working under supervision and following detailed instructions
Pay ranges between $22-28.45/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.