05 Sep
|
Solenis
|
Winnipeg
Position SummaryReporting to the Quality Assurance Manager, this position is responsible for ensuring that Solenis’s operations and policies comply with necessary regulations. The role assists the London facility with creating and maintaining SOPs, ensuring SOPs are trained as necessary, assists with audits (internal and external), compliance checks in Production, and investigates any quality issues that arise in Production or in the lab. The position also actively participates and complies with the Health and Environmental program, including training initiatives and following all policies and procedures. The role works in a team environment and is required to assist others as necessary.Key ResponsibilitiesEmploy safe work habits and comply with all applicable safety requirements.Work closely with Quality Assurance, Plant Management, Production Teams, and QA Technicians at other plant sites.Create, update, and maintain all SOPs for the plant, ensuring information is captured and documented properly.Help develop and maintain the ISO Training matrix to ensure plant compliance with ISO training.Prepare Annual Product reviews for Drugs products to be compliant with Health Canada and FDA requirements.Participate in all audits (FDA, HC, ISO, Halal, Kosher, etc.) and prepare required paperwork for auditors.Conduct Annual Health Canada GMP self‑audit to be compliant with Health Canada regulations.Perform GMP and ISO 9001 & ISO 14001 internal audits as scheduled.Participate in daily QA lab activities as required (wet chemistry testing, positive releases, standard preparation and calculation, releasing raw materials for production).Responsible for internal micro water testing.Review, inspect, and authorize the release of DIN products (GMP) and perform routine stability testing on plant‑manufactured goods and imported DIN products.Print and file various calibration reports, PMs, NA SOPs.Train and assist plant personnel in the use and standardization of laboratory equipment and procedures.Train new lab personnel in procedures,
product analysis, and instrumentation use and maintenance.Participate in continuous improvement activities such as 5 Why investigations, Kaizen, TPM.Be able to change shifts to cover vacation and business needs.Perform other duties as assigned.Required QualificationsMinimum Education: Bachelor’s in chemistry or related science with a minor in chemistry, or equivalent college education.Minimum Experience: 1+ years of experience in a Quality Control environment within a GMP regulated facility.Experience with IR, UV/VIS, HPLC, and GC instruments.Working knowledge of computer applications such as email, MS Office, SAP (a plus).Additional QualificationsOrganizational Skills: Ability to work in a paced environment, multitask, and follow directions.Self Starter: Takes initiative.Adaptability: Adheres to changing priorities and deadlines; copes effectivelywith change.Safety Focused: Dedicated to the health and safety of yourself and colleagues.Professional Communication Skills: Communicates well with employees, visitors, vendors, and customers.Problem Solving: Analytical, problem‑solving, and creative.Attention to Detail: Completes accurate data and develops accurate written materials.Teamwork: Respectful, collaborative team player.Ability to work overtime, evenings, and weekends when necessary.CompensationThe expected compensation range for this position is between $50,030.00 and $66,710.00 plus discretionary bonuses.Equal Prospect StatementSolenis is proud to be an equal opportunity employer. Applications from all qualified individuals are welcome and will be considered without regard to any ground protected by human rights legislation, including race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, gender identity, gender expression, age, record of offences, marital status, family status, and disability. Solenis provides reasonable accommodation to individuals with disabilities in the recruitment process and invites candidates to let us know about their accommodation needs.#J-18808-Ljbffr
📌 Compliance Associate - C$50,030 - C$66,710 A Year (Winnipeg)
🏢 Solenis
📍 Winnipeg